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Fragmin Dalteparin Sodium 25000 [iU]/mL Injection, 1 vial — NDC 00069-0232-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Fragmin Dalteparin Sodium 25000 [iU]/mL Injection, 1 vial — NDC 0069-0232-01 (Billing 00069-0232-01)

by Pfizer Laboratories Div Pfizer Inc · 1 VIAL, MULTI-DOSE in 1 CARTON / 3.8 mL in 1 VIAL, MULTI-DOSE

This is a package of 1 vial of Fragmin Dalteparin Sodium 25000 [iU]/mL Injection from Pfizer Laboratories Div Pfizer Inc, marketed since Apr 2015 and currently FDA-listed. It is this product's only package size.

NDC 00069-0232-01
🏷️ FDA NDC (as labeled) 0069-0232-01 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0069-0232-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0069 labeler · 0232 product · 01 package
Package marketed since
Apr 1, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0069023201 0
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0069-0232-01
Product NDC 0069-0232
11-digit billing NDC 00069023201
NCPDP billing unit ML — per mL (volume)
RxCUI 978725, 978727, 978733, 978735, 978736, 978737, 978740, 978741,
UNII 12M44VTJ7B
Application # NDA020287
SPL Set ID 23527b8b-9b28-4e6d-9751-33b143975ac7
Established class (EPC) Anti-coagulant; Heparin; Low Molecular Weight Heparin
Chemical class Low-Molecular-Weight
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-04-01
Route SUBCUTANEOUS
Dosage form INJECTION
Substance DALTEPARIN SODIUM

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 83101010102080
GPI class Fragmin
GCN Seq No 039503
GCN 95776
HICL code 007429
Ingredient (HICL) Dalteparin Sodium,Porcine
HIC1 code M
Therapeutic class — broad (HIC1) Blood
HIC2 code M9
Therapeutic class — intermediate (HIC2) Drugs Given To Alter Blood Coagulation
HIC3 code M9K
Therapeutic class — specific (HIC3) Heparin And Related Preparations
AHFS code 20:12.04.16
AHFS class Heparins
FDB label name FRAGMIN 95,000 UNIT/3.8 ML VL
FDB brand name Fragmin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 039503
  • GCN: 95776
  • GPI-14 (Medi-Span): 83101010102080
  • HICL (First Databank): 007429
  • AHFS class code: 20:12.04.16
  • RxCUI (RxNorm): 978725
Why two NDCs? The FDA registers this code as 0069-0232-01 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00069-0232-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Low Molecular Weight Heparin class.

Pharmacologic class Low Molecular Weight Heparin, Anti-coagulant
Drug family (ATC) Heparin group
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name FRAGMIN 95,000 UNIT/3.8 ML VL Ingredient Dalteparin Sodium,Porcine
📗 Our plain-language guide HelloPharmacist
  • It helps prevent and treat dangerous blood clots. Your prescriber may use it after hip or abdominal surgery, during an illness that limits movement, with aspirin for unstable angin...
  • It is an injection under the skin, once or twice a day depending on your situation. Never inject it into a muscle, and don't mix it with other injections. Follow your prescriber's...
  • Bruising, bleeding, pain at the injection site, and small collections of blood (hematomas) there are the most common. Some people have a mild platelet drop or a temporary rise in l...
  • Call right away for bleeding that won't stop, black or bloody stools, or blood in your urine. Also call for any leg weakness or numbness, new back pain, or bowel or bladder changes...
📖 Read our full Dalteparin Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Dalteparin may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Dalteparin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $745.25 $745.25 / 1 vial
Medicare Part B allowsASP · J1645 $48.413 / J1645 unit —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0069-0232-01
11-digit billing NDC00069-0232-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1645
DescriptorINJECTION, DALTEPARIN SODIUM, PER 2500 IU
Billing units / pkg10 units
How the units are derivedThis package is 3.8 ML; the HCPCS unit is 2500 IU, so one package = 10 billing units.
Medicare Part B spend (2025 (Q1-Q4))$3,784 · 56 claims · $67.57 per claim (all NDCs under J1645)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00069-0232-01 You're viewing this Main listing 1 VIAL, MULTI-DOSE in 1 CARTON / 3.8 mL in 1 VIAL, MULTI-DOSE 2015-04-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fragmin 25000 [iU]/mLthis 00069-0232-01 Pfizer 1 vial — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2015
On the market since
Apr 2015
📍
2026
Currently FDA-listed
11 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Dalteparin Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 14 mg / 1 mL UNII LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerPfizer Laboratories Div Pfizer Inc
Application holderPFIZER INC
FDA applicationNDA020287 (NDA)
Labeler code00069
First marketedApr 2015
Product typeHuman Prescription Drug
Portfolio242 products on file

More NDCs from Pfizer Laboratories Div Pfizer Inc labeler code 00069

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: SPINAL/EPIDURAL HEMATOMAS Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.

Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • Use of indwelling epidural catheters • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants. • A history of traumatic or repeated epidural or spinal punctures • A history of spinal deformity or spinal surgery • Optimal timing between the administration of FRAGMIN and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment.

If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis [see Warnings and Precautions (5.1) and Drug Interactions (7) ] . WARNING: SPINAL/EPIDURAL HEMATOMAS See full prescribing information for complete boxed warning.

Epidural or spinal hematomas may occur in patients who are anticoagulated with low molecular weight heparins (LMWH) or heparinoids and are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures.

Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: • Use of indwelling epidural catheters • Concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants. • A history of traumatic or repeated epidural or spinal punctures • A history of spinal deformity or spinal surgery • Optimal timing between the administration of FRAGMIN and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment.

If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis ( 5.1 , 7 ).

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE FRAGMIN is a low molecular weight heparin (LMWH) indicated for • Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction ( 1.1 ) • Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery or medical patients with severely restricted mobility during acute illness ( 1.2 ) • Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months ( 1.3 ) • Treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence in pediatric patients from birth (gestational age at least 35 weeks) ( 1.4 ) • Limitations of Use FRAGMIN is not indicated for the acute treatment of VTE ( 1.5 )

1.1Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction FRAGMIN Injection is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin therapy [see Clinical Studies (14.1) ] .

1.2Prophylaxis of Deep Vein Thrombosis FRAGMIN is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE): • In patients undergoing hip replacement surgery [see Clinical Studies (14.2) ] ; • In patients undergoing abdominal surgery who are at risk for thromboembolic complications [see Clinical Studies (14.3) ] ; • In medical patients who are at risk for thromboembolic complications due to severely restricted mobility during acute illness [see Clinical Studies (14.4) ] .

1.3Extended Treatment of Symptomatic Venous Thromboembolism (VTE) in Adult Patients with Cancer FRAGMIN is indicated for the extended treatment of symptomatic venous thromboembolism (VTE) (proximal DVT and/or PE), to reduce the recurrence of VTE in adult patients with cancer. In these patients, the FRAGMIN therapy begins with the initial VTE treatment and continues for six months [see Clinical Studies (14.5) ] .

1.4Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients FRAGMIN is indicated for the treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in pediatric patients from birth (gestational age at least 35 weeks) .

1.5Limitations of Use FRAGMIN is not indicated for the acute treatment of VTE.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Indication Dosing Regimen Unstable angina and non-Q-wave MI 120 units/kg subcutaneous every 12 hours (with aspirin) ( 2.1 ) DVT prophylaxis in abdominal surgery 2,500 units subcutaneous once daily or 5,000 units subcutaneous once daily or 2,500 units subcutaneous followed by 2,500 units subcutaneous 12 hours later and then 5,000 units subcutaneous once daily ( 2.2 ) DVT prophylaxis in hip replacement surgery Postoperative start – 2,500 units subcutaneous 4 hours to 8 hours after surgery, then 5,000 units subcutaneous once daily, or Preoperative start – day of surgery 2,500 units subcutaneous 2 hours before surgery followed by 2,500 units subcutaneous 4 hours to 8 hours after surgery, then 5,000 units subcutaneous once daily ( 2.2 ) Preoperative start – Evening Before Surgery 5,000 units subcutaneous followed by 5,000 units subcutaneous 4 hours to 8 hours after surgery ( 2.2 ) DVT prophylaxis in medical patients 5,000 units subcutaneous once daily ( 2.2 ) Extended treatment of VTE in adult patients with cancer Month 1: 200 units/kg subcutaneous once daily ( 2.3 ) Months 2 to 6: 150 units/kg subcutaneous once daily ( 2.3 ) Treatment of VTE in pediatric patients (see Table 5 ) ( 2.4 ) Age Group Starting Dose Birth (gestational age at least 35 weeks) to less than 2 Years 150 units/kg twice daily 2 Years to less than 8 Years 125 units/kg twice daily 8 Years to less than 17 Years 100 units/kg twice daily Do not use as intramuscular injection.

FRAGMIN should not be mixed with other injections or infusions ( 2.7 )

2.1Recommended Dosage for Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of FRAGMIN Injection is 120 units/kg of body weight, but not more than 10,000 units, subcutaneously every 12 hours with concurrent oral aspirin (75 mg to 165 mg once daily) therapy. Treatment should be continued until the patient is clinically stabilized. The usual duration of administration is 5 days to 8 days.

Concurrent aspirin therapy is recommended except when contraindicated. Table 1 lists the volume of FRAGMIN in mL (based on the 3.8 mL multiple-dose vial 25,000 units/mL) and quantity of FRAGMIN in units, to be administered for a range of patient weights. Table 1 Quantity and Volume of FRAGMIN to be Administered by Patient Weight Patient weight (kg) <50 kg 50 kg to 59 kg 60 kg to 69 kg 70 kg to 79 kg 80 kg to 89 kg ≥90 kg Quantity of FRAGMIN (units) 5,500 units 6,500 units 7,500 units 9,000 units 10,000 units 10,000 units Volume of FRAGMIN (mL) 95,000 units / 3.8 mL 0.22 mL 0.26 mL 0.3 mL 0.36 mL 0.4 mL 0.4 mL

2.2Prophylaxis of Deep Vein Thrombosis Prophylaxis of VTE Following Hip Replacement Surgery : Table 2 presents the dosing options for patients undergoing hip replacement surgery. The usual duration of administration is 5 days to 10 days after surgery; up to 14 days of treatment with FRAGMIN have been well tolerated in clinical trials. Table 2 Dosing Options for Patients Undergoing Hip Replacement Surgery Timing of First Dose of FRAGMIN Dose of FRAGMIN to be Given Subcutaneously 10 Hours to 14 Hours Before Surgery Within 2 Hours Before Surgery 4 Hours to 8 Hours After Surgery Or later, if hemostasis has not been achieved.

Postoperative Period Up to 14 days of treatment was well tolerated in controlled clinical trials, where the usual duration of treatment was 5 days to 10 days postoperatively. Postoperative Start --- --- 2,500 units Allow a minimum of 6 hours between this dose and the dose to be given on Postoperative Day 1. Adjust the timing of the dose on Postoperative Day 1 accordingly.

5,000 units once daily Preoperative Start - Day of Surgery --- 2,500 units 2,500 units 5,000 units once daily Preoperative Start - Evening Before Surgery Allow approximately 24 hours between doses. 5,000 units --- 5,000 units 5,000 units once daily Abdominal Surgery: In patients undergoing a… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 170 words ▾

3 DOSAGE FORMS AND STRENGTHS FRAGMIN (dalteparin sodium) injection is a sterile, aqueous, clear, colorless or straw-colored solution for injection, available in the following dosage forms and strengths: • Injection: 2,500 units/ 0.2 mL, 5,000 units/ 0.2 mL, 7,500 units/ 0.3 mL, 12,500 units/ 0.5 mL, 15,000 units/ 0.6 mL, and 18,000 units/ 0.72 mL sterile, single-dose, prefilled syringes preassembled with a needle guard device. • Injection: 10,000 units/mL sterile, single-dose, graduated syringes preassembled with a needle guard device. • Injection: 95,000 units/ 3.8 mL (25,000 units/mL) sterile, multiple-dose vials. • Injection: 10,000 units/ 4 mL (2,500 units/mL) sterile, single-dose vials. • Injection: 2,500 units/ 0.2 mL, 5,000 units/ 0.2 mL, 7,500 units/ 0.3 mL, 12,500 units/ 0.5 mL, 15,000 units/ 0.6 mL, and 18,000 units/ 0.72 mL single-dose prefilled syringes ( 3 ) • Injection: 10,000 units/mL single-dose graduated syringes ( 3 ) • Injection: 95,000 units/ 3.8 mL (25,000 units/mL) multiple-dose vials ( 3 ) • Injection: 10,000 units/ 4 mL (2,500 units/mL) single-dose vials ( 3 )

⛔ Contraindications 163 words ▾

4 CONTRAINDICATIONS FRAGMIN is contraindicated in: • Patients with active major bleeding. • Patients with a history of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis. • Patients with prior hypersensitivity to dalteparin sodium (e.g., pruritis, rash, anaphylactic reactions) [see Adverse Reactions (6.1) ] . • Patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN [see Boxed Warning and Warnings and Precautions (5.1) ] ; o As a treatment for unstable angina and non-Q-wave MI. o For prolonged VTE prophylaxis. • Patients with prior hypersensitivity to heparin or pork products. • Active major bleeding ( 4 ) • History of heparin induced thrombocytopenia or heparin induced thrombocytopenia with thrombosis ( 4 ) • Hypersensitivity to dalteparin sodium ( 4 , 6.1 ) • In patients undergoing Epidural/Neuraxial anesthesia, do not administer FRAGMIN ( 5.1 ) o As a treatment for unstable angina and non-Q-wave MI o For prolonged VTE prophylaxis ( 4 ) • Hypersensitivity to heparin or pork products ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hemorrhage: Use caution in conditions with increased risk of hemorrhage ( 5.1 ) • Thrombocytopenia: Monitor thrombocytopenia of any degree closely ( 5.2 ) • Benzyl Alcohol Preservative: Do not use multiple-dose formulations in neonates and infants as they contain benzyl alcohol ( 5.3 ) • Laboratory Tests: Periodic blood counts recommended ( 5.4 )

5.1Risk of Hemorrhage including Spinal/Epidural Hematomas Spinal or epidural hemorrhage and subsequent hematomas can occur with the associated use of low molecular weight heparins or heparinoids and neuraxial (spinal/epidural) anesthesia or spinal puncture. The risk of these events is higher with the use of post-operative indwelling epidural catheters, with the concomitant use of additional drugs affecting hemostasis such as NSAIDs, with traumatic or repeated epidural or spinal puncture, or in patients with a history of spinal surgery or spinal deformity [see Boxed Warning , Adverse Reactions (6.2) , and Drug Interactions (7) ] .

To reduce the potential risk of bleeding associated with the concurrent use of FRAGMIN and epidural or spinal anesthesia/analgesia or spinal puncture, consider the pharmacokinetic profile of FRAGMIN [see Clinical Pharmacology (12.3) ]. Placement or removal of an epidural catheter or lumbar puncture is best performed when the anticoagulant effect of FRAGMIN is low; however, the exact timing to reach a sufficiently low anticoagulant effect in each patient is not known. No additional hemostasis-altering medications should be administered due to the additive effects.

Patients on preoperative FRAGMIN thromboprophylaxis can be assumed to have altered coagulation. The first postoperative FRAGMIN thromboprophylaxis dose (2,500 units) should be administered 6 hours to 8 hours postoperatively. The second postoperative dose (2,500 units or 5,000 units) should occur no sooner than 24 hours after the first dose.

Placement or removal of a catheter should be delayed for at least 12 hours after administration of 2,500 units once daily of FRAGMIN, at least 15 hours after the administration of 5,000 units once daily of FRAGMIN, and at least 24 hours after the administration of higher doses (200 units/kg once daily, 120 units/kg twice daily) of FRAGMIN. Anti-Xa levels are still detectable at these time points, and these delays are not a guarantee that neuraxial hematoma will be avoided. Although a specific recommendation for timing of a subsequent FRAGMIN dose after catheter removal cannot be made, consider delaying this next dose for at least 4 hours, based on a benefit-risk assessment considering both the risk for thrombosis and the risk for bleeding in the context of the procedure and patient risk factors.

For patients with creatinine clearance <30 mL/minute, additional considerations are necessary because elimination of FRAGMIN may be more prolonged; consider doubling the timing of removal of a catheter, at least 24 hours for the lower prescribed dose of FRAGMIN (2,500 units or 5,000 units once daily) and at least 48 hours for the higher dose (200 units/kg once daily, 120 units/kg twice daily) [see Clinical Pharmacology (12.3) ]. Should the physician decide to administer anticoagulation in the context of epidural or spinal anesthesia/analgesia or lumbar puncture, frequent monitoring must be exercised to detect any signs and symptoms of neurological impairment such as midline back pain, sensory and motor deficits (numbness or weakness in lower limbs), bowel and/or bladder dysfunction.

Instruct patients to report immediately if they experience any of the above signs or symptoms. If signs or symptoms of spinal hematoma are suspected, initiate urgent diagnosis and treatment including consideration for spinal cord decompression even though such treatment may not prevent or reverse neurological sequelae. Use FRAGMIN with extreme caution in patients who have an increased risk of hemorrhage, such as those with severe uncontrolled hypertension, bacteria… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in more detail in other sections of the prescribing information . • Risk of Hemorrhage including Spinal/Epidural Hematomas [see Warnings and Precautions (5.1) ] • Thrombocytopenia [see Warnings and Precautions (5.2) ] • Benzyl Alcohol Preservative Risk to Premature Infants [see Warnings and Precautions (5.3) ] Most common adverse reactions (>1%) are: bleeding (including hemorrhage), thrombocytopenia (Type I), hematoma at the injection site, pain at the injection site, transient elevation of transaminases ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not accurately reflect the rates observed in practice. Hemorrhage The most commonly reported adverse reactions are hematoma at the injection site and hemorrhagic complications. The risk for bleeding varies with the indication and may increase with higher doses.

Unstable Angina and Non-Q-Wave Myocardial Infarction Table 7 summarizes major bleeding reactions that occurred with FRAGMIN, heparin, and placebo in clinical trials of unstable angina and non-Q-wave myocardial infarction. Table 7 Major Bleeding Reactions in Unstable Angina and Non-Q-Wave Myocardial Infarction Indication Dosing Regimen Unstable Angina and Non-Q-Wave MI FRAGMIN 120 units/kg/12 hours subcutaneous Treatment was administered for 5 days to 8 days. n (%) Heparin Heparin intravenous infusion for at least 48 hours, APTT 1.5 to 2 times control, then 12,500 units subcutaneously every 12 hours for 5 days to 8 days. intravenous and subcutaneous n (%) Placebo every 12 hours subcutaneous n (%) Major Bleeding Reactions Aspirin (75 mg to 165 mg per day) and beta blocker therapies were administered concurrently. , Bleeding reactions were considered major if: 1) accompanied by a decrease in hemoglobin of ≥2 g/dL in connection with clinical symptoms; 2) a transfusion was required; 3) bleeding led to interruption of treatment or death; or 4) intracranial bleeding.

15/1497 (1.0) 7/731 (1.0) 4/760 (0.5) Hip Replacement Surgery Table 8 summarizes: 1) all major bleeding reactions and, 2) other bleeding reactions possibly or probably related to treatment with FRAGMIN (preoperative dosing regimen), warfarin sodium, or heparin in two hip replacement surgery clinical trials. Table 8 Bleeding Reactions Following Hip Replacement Surgery Indication FRAGMIN vs Warfarin Sodium FRAGMIN vs Heparin Dosing Regimen Dosing Regimen Hip Replacement Surgery FRAGMIN Includes three treated patients who did not undergo a surgical procedure.

5,000 units once daily subcutaneous Warfarin Sodium Warfarin sodium dosage was adjusted to maintain a prothrombin time index of 1.4 to 1.5, corresponding to an International Normalized Ratio (INR) of approximately 2.5. oral FRAGMIN Includes two treated patients who did not undergo a surgical procedure. 5,000 units once daily subcutaneous Heparin 5,000 units three times a day subcutaneous n (%) n (%) n (%) n (%) Major Bleeding Reactions A bleeding event was considered major if: 1) hemorrhage caused a significant clinical event, 2) it was associated with a hemoglobin decrease of ≥2 g/dL or transfusion of 2 or more units of blood products, 3) it resulted in reoperation due to bleeding, or 4) it involved retroperitoneal or intracranial hemorrhage.

7/274 (2.6) 1/279 (0.4) 0 3/69 (4.3) Other Bleeding Reactions Occurred at a rate of at least 2% in the group treated with FRAGMIN 5,000 units once daily. Hematuria 8/274 (2.9) 5/279 (1.8) 0 0 Wound Hematoma 6/274 (2.2) 0 0 0 Injection Site Hematoma 3/274 (1.1) NA 2/69 (2.9) 7/69 (10.1) Six of the patients treated with FRAGMIN experienced seven major bleeding… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 53 words ▾

7 DRUG INTERACTIONS The use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding [see Warnings and Precautions (5) ] . The use of FRAGMIN in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents may increase the risk of bleeding ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from published literature and postmarketing reports have not reported a clear association with FRAGMIN and adverse developmental outcomes. There are risks to the mother associated with untreated VTE in pregnancy, and a potential for adverse effects on the preterm infant when FRAGMIN is used in pregnancy (see Clinical Considerations ) . In animal reproduction studies, there was no evidence of embryo-fetal toxicity or teratogenicity when dalteparin sodium was administered to pregnant rats and rabbits during organogenesis at doses 2 to 4 times (rats) and 4 times (rabbits) the human dose of 100 units/kg dalteparin based on the body surface area (see Data ) .

Because animal reproduction studies are not always predictive of human response, FRAGMIN should be used during pregnancy only if clearly needed. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data describe that women with a previous history of VTE in pregnancy are at higher risk for recurrence during subsequent pregnancies compared to those with no risk factor for VTE (4.5% versus 2.7% respectively, relative risk 1.7, 95% CI: 1.0–2.8). Fetal/Neonatal Adverse Reactions Cases of "gasping syndrome" have occurred in premature infants when large amounts of benzyl alcohol have been administered (99 mg/kg/day to 404 mg/kg/day).

The 3.8 mL multiple-dose vials of FRAGMIN contain 14 mg/mL of benzyl alcohol [see Warnings and Precautions (5.3) ] . Data Animal Data In reproductive and developmental toxicity studies, pregnant rats and rabbits received dalteparin sodium during organogenesis at intravenous doses up to 2,400 units/kg (14,160 units/m 2 ) (rats) and 4,800 units/kg (40,800 units/m 2 ) (rabbits). These exposures were 2 to 4 times (rats) and 4 times (rabbits) the human dose of 100 units/kg dalteparin based on the body surface area.

These studies revealed no evidence of teratogenicity or embryo-fetal toxicity.

8.2Lactation Risk Summary Limited published data indicate that dalteparin is present in human milk in small amounts (see Data ) . No adverse effects on the breastfed infant have been reported. There are no data on the effects of the drug on milk production.

Oral absorption of dalteparin is expected to be low, but the clinical implications, if any, of this small amount of anticoagulant activity on a breastfed infant are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for FRAGMIN and any potential adverse effects on the breastfed child from FRAGMIN or from the underlying maternal condition. Data A study evaluated samples of maternal blood and breast milk in 15 lactating women receiving prophylactic doses of dalteparin in the immediate postpartum period (days 4 to 8 after Cesarean-section).

The samples were collected before and 3 hours to 4 hours after daily injections of 2500 units dalteparin. Small amounts of anti-Xa activity (range <0.005 to 0.037 units/mL) in breast milk were detected in 11 of the 15 women. Because this study evaluated colostrum or transitional milk at a single timepoint during the 24 hours dosing interval, the clinical relevance of this data is unclear in regard to passage of drug into mature milk and the quantification of drug exposure to the infant over the full dosing interval.

8.4Pediatric Use The safety and effectiveness of FRAGMIN for the treatment of symptomatic venous thromboembolism (VTE) in patients have been established in pediatric patients from birth (gestational age at least 35 weeks) to… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Available data from published literature and postmarketing reports have not reported a clear association with FRAGMIN and adverse developmental outcomes. There are risks to the mother associated with untreated VTE in pregnancy, and a potential for adverse effects on the preterm infant when FRAGMIN is used in pregnancy (see Clinical Considerations ) . In animal reproduction studies, there was no evidence of embryo-fetal toxicity or teratogenicity when dalteparin sodium was administered to pregnant rats and rabbits during organogenesis at doses 2 to 4 times (rats) and 4 times (rabbits) the human dose of 100 units/kg dalteparin based on the body surface area (see Data ) .

Because animal reproduction studies are not always predictive of human response, FRAGMIN should be used during pregnancy only if clearly needed. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data describe that women with a previous history of VTE in pregnancy are at higher risk for recurrence during subsequent pregnancies compared to those with no risk factor for VTE (4.5% versus 2.7% respectively, relative risk 1.7, 95% CI: 1.0–2.8). Fetal/Neonatal Adverse Reactions Cases of "gasping syndrome" have occurred in premature infants when large amounts of benzyl alcohol have been administered (99 mg/kg/day to 404 mg/kg/day).

The 3.8 mL multiple-dose vials of FRAGMIN contain 14 mg/mL of benzyl alcohol [see Warnings and Precautions (5.3) ] . Data Animal Data In reproductive and developmental toxicity studies, pregnant rats and rabbits received dalteparin sodium during organogenesis at intravenous doses up to 2,400 units/kg (14,160 units/m 2 ) (rats) and 4,800 units/kg (40,800 units/m 2 ) (rabbits). These exposures were 2 to 4 times (rats) and 4 times (rabbits) the human dose of 100 units/kg dalteparin based on the body surface area.

These studies revealed no evidence of teratogenicity or embryo-fetal toxicity.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of FRAGMIN for the treatment of symptomatic venous thromboembolism (VTE) in patients have been established in pediatric patients from birth (gestational age at least 35 weeks) to less than 17 years of age. Use of FRAGMIN for this indication is supported by evidence from well-controlled studies in adults with additional pharmacokinetic, pharmacodynamic, efficacy, and safety data from two separate prospective studies in pediatric patients aged 1 month and older with symptomatic VTE, and a retrospective study in neonatal patients aged birth (gestational age at least 35 weeks) to 1 month with VTE [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.5 ] .

The frequency, type and severity of adverse reactions observed were generally consistent with those observed in adults. Use preservative-free FRAGMIN in neonates and infants. Serious adverse reactions including fatal reactions and the “gasping syndrome” occurred in premature neonates and low-birth weight infants in the neonatal intensive care unit who received benzyl alcohol preserved medications.

In these cases, benzyl alcohol dosages of 99 mg/kg/day to 234 mg/kg/day produced high levels of benzyl alcohol and its metabolites in the blood and urine (blood levels of benzyl alcohol were 0.61 mmol/L to 1.378 mmol/L). Additional adverse reactions included gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol.

When prescribing FRAGMIN multiple-dose vials in infants consider the combined daily metabolic load of benzyl alcohol from all sources including FRAGMIN multiple-dose vials (FRAGMIN contains 14 mg of benzyl alcohol per mL) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known [see Warnings and Precautions (5.3) ] . The long-term effects of treatment with FRAGMIN in pediatric patients, including effects on growth and bone metabolism, are unknown.

🧓 Geriatric Use 115 words ▾

8.5Geriatric Use Of the total number of patients in clinical studies of FRAGMIN, 5,516 patients were 65 years of age or older and 2,237 were 75 or older. No overall differences in effectiveness were observed between these subjects and younger subjects. Some studies suggest that the risk of bleeding increases with age.

Postmarketing surveillance and literature reports have not revealed additional differences in the safety of FRAGMIN between elderly and younger patients. Give careful attention to dosing intervals and concomitant medications (especially antiplatelet medications) in geriatric patients, particularly in those with low body weight (<45 kg) and those predisposed to decreased renal function [see Warnings and Precautions (5) and Clinical Pharmacology (12) ] .

🆘 Overdosage 171 words ▾

10 OVERDOSAGE An excessive dosage of FRAGMIN Injection may lead to hemorrhagic complications. These may generally be stopped by slow intravenous injection of protamine sulfate (1% solution), at a dose of 1 mg protamine for every 100 anti-Xa units of FRAGMIN given. If the APTT measured 2 hours to 4 hours after the first infusion remains prolonged, a second infusion of 0.5 mg protamine sulfate per 100 anti-Xa units of FRAGMIN may be administered.

Even with these additional doses of protamine, the APTT may remain more prolonged than would usually be found following administration of unfractionated heparin. In all cases, the anti-Xa activity is never completely neutralized (maximum about 60% to 75%). Take particular care to avoid overdosage with protamine sulfate.

Administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions. Because fatal reactions, often resembling anaphylaxis, have been reported with protamine sulfate, give protamine sulfate only when resuscitation techniques and treatment for anaphylactic shock are readily available. For additional information, consult the labeling of Protamine Sulfate Injection, USP, products.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dalteparin is a low molecular weight heparin with antithrombotic properties. It acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin. In humans, dalteparin potentiates preferentially the inhibition of coagulation Factor Xa, while only slightly affecting the activated partial thromboplastin time (APTT).

12.2Pharmacodynamics Doses of FRAGMIN Injection of up to 10,000 anti-Xa units administered subcutaneously as a single dose or two 5,000 units doses 12 hours apart to healthy subjects did not produce a significant change in platelet aggregation, fibrinolysis, or global clotting tests such as prothrombin time (PT), thrombin time (TT) or APTT. Subcutaneous administration of doses of 5,000 units twice daily of FRAGMIN for seven consecutive days to patients undergoing abdominal surgery did not markedly affect APTT, Platelet Factor 4 (PF4), or lipoprotein lipase.

12.3Pharmacokinetics Adults Mean peak levels of plasma anti-Xa activity following single subcutaneous doses of 2,500 units, 5,000 units and 10,000 units were 0.19 ± 0.04 units/mL, 0.41 ± 0.07 units/mL and 0.82 ± 0.10 units/mL, respectively, and were attained in about 4 hours in most subjects. Absolute bioavailability in healthy volunteers, measured as the anti-Xa activity, was 87 ± 6%. Increasing the dose from 2,500 units to 10,000 units resulted in an overall increase in anti-Xa AUC that was greater than proportional by about one-third.

Peak anti-Xa activity increased more or less linearly with dose over the same dose range. There appeared to be no appreciable accumulation of anti-Xa activity with twice-daily dosing of 100 units/kg subcutaneously for up to 7 days. The volume of distribution for dalteparin anti-Xa activity was 40 mL/kg to 60 mL/kg.

The mean plasma clearances of dalteparin anti-Xa activity in normal volunteers following single intravenous bolus doses of 30 and 120 anti-Xa units/kg were 24.6 ± 5.4 mL/hr/kg and 15.6 ± 2.4 mL/hr/kg, respectively. The corresponding mean disposition half-lives were 1.47 ± 0.3 hours and 2.5 ± 0.3 hours. Following intravenous doses of 40 units/kg and 60 units/kg, mean terminal half-lives were 2.1 ± 0.3 hours and 2.3 ± 0.4 hours, respectively.

Longer apparent terminal half-lives (3 hours to 5 hours) are observed following subcutaneous dosing, possibly due to delayed absorption. In patients with chronic renal insufficiency requiring hemodialysis, the mean terminal half-life of anti-Xa activity following a single intravenous dose of 5,000 units FRAGMIN was 5.7 ± 2.0 hours, i.e., considerably longer than values observed in healthy volunteers, therefore, greater accumulation can be expected in these patients. Pediatric Patients The pharmacokinetics of twice-daily subcutaneous dalteparin, measured as anti-Xa activity, was characterized in 89 pediatric patients with or without cancer from two clinical studies and 1 observational study.

Dalteparin pharmacokinetics (PK) were described by a 1-compartment model with linear absorption and elimination and PK parameters are shown in Table 12. After correcting for the body weight, clearance (CL/F) decreased with increasing age, while volume of distribution at steady-state (V d /F) remained similar. The mean elimination half-life increased with age.

Table 12 Pharmacokinetic Parameters of Dalteparin in Pediatric Population Abbreviations: CL=clearance; F=absolute bioavailability; SD=standard deviation; t ½β =elimination half-life; V d =volume of distribution. Parameter 3 Weeks to <8 Weeks ≥8 Weeks to <2 Years ≥2 Years to <8 Years ≥8 Years to <12 Years ≥12 Years to <20 Years Median Age (range) (years) 0.06 (0.04 – 0.14) 0.5 (0.2 – 1.91) 4.47 (2.01 – 7.6) 9.62 (8.01 – 10.5) 15.9 (12.0 – 19.5) Derived Mean (SD) CL/F (mL/h/kg) 55.8 (3.91) 40.4 (8.49) 26.7 (4.75) 22.4 (3.40) 18.8 (3.01) Derived Mean (SD) V d /F (mL/kg) 181 (15.3) 175 (55.3) 160 (25.6) 165 (27.3) 171 (38.9) Derived Mean (SD) t ½β (h) 2.25 (0.173) 3.02 (0.688) 4.27 (1.… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 48 words ▾

12.1Mechanism of Action Dalteparin is a low molecular weight heparin with antithrombotic properties. It acts by enhancing the inhibition of Factor Xa and thrombin by antithrombin. In humans, dalteparin potentiates preferentially the inhibition of coagulation Factor Xa, while only slightly affecting the activated partial thromboplastin time (APTT).

📦 How Supplied / Storage and Handling 219 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING FRAGMIN (dalteparin sodium) injection, USP, is a sterile, aqueous, clear, colorless or straw-colored solution available as follows: Presentation Strength Package Size NDC Number Single-dose prefilled syringe Single-dose prefilled syringe, affixed with a 27-gauge × 1/2 inch needle and preassembled with UltraSafe Passive™ Needle Guard devices. Discard unused portion. 2,500 units / 0.2 mL 10 Syringes 0069-0195-02 5,000 units / 0.2 mL 10 Syringes 0069-0196-02 7,500 units / 0.3 mL 10 Syringes 0069-0206-02 Single-dose graduated syringe Single-dose graduated syringe, affixed with a 27-gauge × 1/2 inch needle and preassembled with UltraSafe Passive™ Needle Guard devices.

UltraSafe Passive™ Needle Guard is a trademark of Safety Syringes, Inc. Discard unused portion. 10,000 units / mL 10 Syringes 0069-0217-02 Single-dose prefilled syringe 12,500 units / 0.5 mL 10 Syringes 0069-0220-02 15,000 units / 0.6 mL 10 Syringes 0069-0223-02 18,000 units / 0.72 mL 10 Syringes 0069-0228-02 Multiple-dose vial 95,000 units / 3.8 mL (25,000 units / mL) 3.8 mL vial 0069-0232-01 Single-dose vial 10,000 units / 4 mL (2,500 units / mL) 10 vials 0069-0253-10 Store at 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Latex Allergy: The needle shield of the prefilled syringe may contain natural rubber latex [see Dosage and Administration (2.7) ] .

📦 Storage and Handling 43 words ▾

Store at 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Latex Allergy: The needle shield of the prefilled syringe may contain natural rubber latex [see Dosage and Administration (2.7) ] .

📋 Description ~1 min read ▾

11 DESCRIPTION FRAGMIN Injection (dalteparin sodium injection) is a sterile, low molecular weight heparin. It is available in single-dose, prefilled syringes preassembled with a needle guard device, and multiple-dose vials. With reference to the W.H.O.

First International Low Molecular Weight Heparin Reference Standard, each syringe contains either 2,500 units, 5,000 units, 7,500 units, 10,000 units, 12,500 units, 15,000 units or 18,000 anti-Xa international units (units), equivalent to 16 mg, 32 mg, 48 mg, 64 mg, 80 mg, 96 mg or 115.2 mg dalteparin sodium, respectively. Each multiple-dose vial contains 25,000 anti-Xa units per 1 mL (equivalent to 160 mg dalteparin sodium), for a total of 95,000 anti-Xa units per vial. Each single-dose vial contains 2,500 anti-Xa units per 1 mL (equivalent to 16 mg dalteparin sodium) for a total of 10,000 anti-Xa units per vial.

Each prefilled syringe also contains Water for Injection and sodium chloride, when required, to maintain physiologic ionic strength. The prefilled syringes are preservative-free. Each multiple-dose vial also contains Water for Injection and 14 mg of benzyl alcohol per mL as a preservative.

The pH of both formulations is 5.0 to 7.5. When necessary, the pH of FRAGMIN is adjusted with hydrochloric acid and/or sodium hydroxide [see Dosage and Administration (2.7) and How Supplied/Storage and Handling (16) ] . Dalteparin sodium is produced through controlled nitrous acid depolymerization of sodium heparin from porcine intestinal mucosa followed by a chromatographic purification process.

It is composed of strongly acidic sulfated polysaccharide chains (oligosaccharide, containing 2,5-anhydro-D-mannitol residues as end groups) with an average molecular weight of 5,000 and about 90% of the material within the range 2,000–9,000. The molecular weight distribution is: <3000 daltons 3.0–15% 3,000 to 8,000 daltons 65.0–78.0% >8,000 daltons 14.0–26.0% Structural Formula Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Risk of Hemorrhage including Spinal/Epidural Hematomas If patients have had neuraxial anesthesia or spinal puncture, and particularly, if they are taking concomitant NSAIDs, platelet inhibitors, or other anticoagulants, inform the patients to watch for signs and symptoms of spinal or epidural hematoma, such as tingling, numbness (especially in the lower limbs) and muscular weakness. If any of these symptoms occur the patient should contact his or her physician immediately.

Additionally, the use of aspirin and other NSAIDs may enhance the risk of hemorrhage. Discontinue their use prior to FRAGMIN therapy whenever possible; if co-administration is essential, the patient's clinical and laboratory status should be closely monitored [see Drug Interactions (7) ] . Inform Patients : • of the instructions for injecting FRAGMIN if their therapy is to continue after discharge from the hospitals. • it may take them longer than usual to stop bleeding. • they may bruise and/or bleed more easily when they are treated with FRAGMIN. • they should report any unusual bleeding, bruising, or signs of thrombocytopenia (such as a rash of dark red spots under the skin) to their physician [see Warnings and Precautions (5.1 , 5.2) ] . • to tell their physicians and dentists they are taking FRAGMIN and/or any other product known to affect bleeding before any surgery is scheduled and before any new drug is taken [see Warnings and Precautions (5.1) ] . • to tell their physicians and dentists of all medications they are taking, including those obtained without a prescription, such as aspirin or other NSAIDs [see Drug Interactions (7) ] . • Risks are associated with benzyl alcohol in neonates, infants, and pregnant women [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1) ] . • to tell their physicians and care givers if they are allergic to natural rubber latex [see Dosage and Administration (2.7) ].

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Adults Mean peak levels of plasma anti-Xa activity following single subcutaneous doses of 2,500 units, 5,000 units and 10,000 units were 0.19 ± 0.04 units/mL, 0.41 ± 0.07 units/mL and 0.82 ± 0.10 units/mL, respectively, and were attained in about 4 hours in most subjects. Absolute bioavailability in healthy volunteers, measured as the anti-Xa activity, was 87 ± 6%. Increasing the dose from 2,500 units to 10,000 units resulted in an overall increase in anti-Xa AUC that was greater than proportional by about one-third.

Peak anti-Xa activity increased more or less linearly with dose over the same dose range. There appeared to be no appreciable accumulation of anti-Xa activity with twice-daily dosing of 100 units/kg subcutaneously for up to 7 days. The volume of distribution for dalteparin anti-Xa activity was 40 mL/kg to 60 mL/kg.

The mean plasma clearances of dalteparin anti-Xa activity in normal volunteers following single intravenous bolus doses of 30 and 120 anti-Xa units/kg were 24.6 ± 5.4 mL/hr/kg and 15.6 ± 2.4 mL/hr/kg, respectively. The corresponding mean disposition half-lives were 1.47 ± 0.3 hours and 2.5 ± 0.3 hours. Following intravenous doses of 40 units/kg and 60 units/kg, mean terminal half-lives were 2.1 ± 0.3 hours and 2.3 ± 0.4 hours, respectively.

Longer apparent terminal half-lives (3 hours to 5 hours) are observed following subcutaneous dosing, possibly due to delayed absorption. In patients with chronic renal insufficiency requiring hemodialysis, the mean terminal half-life of anti-Xa activity following a single intravenous dose of 5,000 units FRAGMIN was 5.7 ± 2.0 hours, i.e., considerably longer than values observed in healthy volunteers, therefore, greater accumulation can be expected in these patients. Pediatric Patients The pharmacokinetics of twice-daily subcutaneous dalteparin, measured as anti-Xa activity, was characterized in 89 pediatric patients with or without cancer from two clinical studies and 1 observational study.

Dalteparin pharmacokinetics (PK) were described by a 1-compartment model with linear absorption and elimination and PK parameters are shown in Table 12. After correcting for the body weight, clearance (CL/F) decreased with increasing age, while volume of distribution at steady-state (V d /F) remained similar. The mean elimination half-life increased with age.

Table 12 Pharmacokinetic Parameters of Dalteparin in Pediatric Population Abbreviations: CL=clearance; F=absolute bioavailability; SD=standard deviation; t ½β =elimination half-life; V d =volume of distribution. Parameter 3 Weeks to <8 Weeks ≥8 Weeks to <2 Years ≥2 Years to <8 Years ≥8 Years to <12 Years ≥12 Years to <20 Years Median Age (range) (years) 0.06 (0.04 – 0.14) 0.5 (0.2 – 1.91) 4.47 (2.01 – 7.6) 9.62 (8.01 – 10.5) 15.9 (12.0 – 19.5) Derived Mean (SD) CL/F (mL/h/kg) 55.8 (3.91) 40.4 (8.49) 26.7 (4.75) 22.4 (3.40) 18.8 (3.01) Derived Mean (SD) V d /F (mL/kg) 181 (15.3) 175 (55.3) 160 (25.6) 165 (27.3) 171 (38.9) Derived Mean (SD) t ½β (h) 2.25 (0.173) 3.02 (0.688) 4.27 (1.05) 5.11 (0.509) 6.28 (0.937)

🧬 Pharmacodynamics 85 words ▾

12.2Pharmacodynamics Doses of FRAGMIN Injection of up to 10,000 anti-Xa units administered subcutaneously as a single dose or two 5,000 units doses 12 hours apart to healthy subjects did not produce a significant change in platelet aggregation, fibrinolysis, or global clotting tests such as prothrombin time (PT), thrombin time (TT) or APTT. Subcutaneous administration of doses of 5,000 units twice daily of FRAGMIN for seven consecutive days to patients undergoing abdominal surgery did not markedly affect APTT, Platelet Factor 4 (PF4), or lipoprotein lipase.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction In a double-blind, randomized, placebo-controlled clinical trial, patients who recently experienced unstable angina with EKG changes or non-Q-wave myocardial infarction (MI) were randomized to FRAGMIN Injection 120 units/kg or placebo every 12 hours subcutaneously. In this trial, unstable angina was defined to include only angina with EKG changes. All patients, except when contraindicated, were treated concurrently with aspirin (75 mg once daily) and beta blockers.

Treatment was initiated within 72 hours of the event (the majority of patients received treatment within 24 hours) and continued for 5 days to 8 days. A total of 1,506 patients were enrolled and treated; 746 received FRAGMIN and 760 received placebo. The mean age of the study population was 68 years (range 40 years to 90 years) and the majority of patients were white (99.7%) and male (63.9%).

The combined incidence of the endpoint of death or myocardial infarction was lower for FRAGMIN compared with placebo at 6 days after initiation of therapy. These results were observed in an analysis of all-randomized and all-treated patients. The combined incidence of death, MI, need for intravenous heparin or intravenous. nitroglycerin, and revascularization was also lower for FRAGMIN than for placebo (see Table 13) .

Table 13 Efficacy of FRAGMIN in the Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction Indication Dosing Regimen FRAGMIN 120 units/kg/every 12 hours subcutaneous n (%) Placebo every 12 hours subcutaneous n (%) All Treated Unstable Angina and Non-Q-Wave MI Patients 746 760 Primary Endpoints - 6 day timepoint Death, MI 13/741 (1.8) p-value = 0.001 36/757 (4.8) Secondary Endpoints - 6 day timepoint Death, MI, intravenous heparin, i.v. nitroglycerin, Revascularization 59/739 (8) 106/756 (14) In a second randomized, controlled trial designed to evaluate long-term treatment with FRAGMIN (6 days to 45 days), data were also collected comparing 1 week (5 days to 8 days) treatment of FRAGMIN 120 units/kg every 12 hours subcutaneously with heparin at an APTT-adjusted dosage.

All patients, except when contraindicated, were treated concurrently with aspirin (100 mg per day to 165 mg per day). Of the 1,499 patients enrolled, 1,482 patients were treated; 751 received FRAGMIN and 731 received heparin. The mean age of the study population was 64 years (range 25 years to 92 years) and the majority of patients were white (96.0%) and male (64.2%).

The incidence of the combined endpoint of death, myocardial infarction, or recurrent angina during this 1-week treatment period (5 days to 8 days) was 9.3% for FRAGMIN and 7.6% for heparin (p = 0.323).

14.2Prophylaxis of Deep Vein Thrombosis in Patients Following Hip Replacement Surgery In an open-label randomized study, FRAGMIN 5,000 units administered once daily subcutaneously was compared with warfarin sodium, administered orally, in patients undergoing hip replacement surgery. Treatment with FRAGMIN was initiated with a 2,500 units dose subcutaneously within 2 hours before surgery, followed by a 2,500 units dose subcutaneously the evening of the day of surgery. Then, a dosing regimen of FRAGMIN 5,000 units subcutaneously once daily was initiated on the first postoperative day.

The first dose of warfarin sodium was given the evening before surgery, then continued daily at a dose adjusted for INR 2 to 3. Treatment in both groups was then continued for 5 days to 9 days postoperatively. Of the 580 patients enrolled, 553 were treated and 550 underwent surgery.

Of those who underwent surgery, 271 received FRAGMIN and 279 received warfarin sodium. The mean age of the study population was 63 years (range 20 years to 92 years) and the majority of patients were white (91.1%) and female (52.9%). The incidence of deep vein thrombosis (DVT), as determined by evaluable venography, was sign… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 79 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Dalteparin sodium has not been tested for its carcinogenic potential in long-term animal studies. It was not mutagenic in the in vitro Ames Test, mouse lymphoma cell forward mutation test and human lymphocyte chromosomal aberration test and in the in vivo mouse micronucleus test. Dalteparin sodium at subcutaneous doses up to 1,200 units/kg (7,080 units/m 2 ) did not affect the fertility or reproductive performance of male and female rats.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 76 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Dalteparin sodium has not been tested for its carcinogenic potential in long-term animal studies. It was not mutagenic in the in vitro Ames Test, mouse lymphoma cell forward mutation test and human lymphocyte chromosomal aberration test and in the in vivo mouse micronucleus test. Dalteparin sodium at subcutaneous doses up to 1,200 units/kg (7,080 units/m 2 ) did not affect the fertility or reproductive performance of male and female rats.

📄 Recent Major Changes 55 words ▾

Indications and Usage, Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients ( 1.4 ) 10/2024 Dosage and Administration, Treatment of Symptomatic Venous Thromboembolism (VTE) in Pediatric Patients ( 2.4 ) 10/2024 Dosage and Administration, Dose Reductions for Thrombocytopenia in Adult Patients with Cancer and in Pediatric Patients with Symptomatic VTE ( 2.5 ) 10/2024

📄 Package Label / Principal Display Panel ~3 min read ▾

PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Label - 0195 0.2 mL NDC 0069-0195-01 Fragmin ® (dalteparin sodium) Injection, USP 2,500 units/0.2 mL For Subcutaneous Use Single-dose prefilled syringe Pfizer Labs Division of Pfizer Inc. NY, NY 10001 Rx only PAA233623 PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Label - 0195

PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Blister Pack Label - 0195 0.2 mL Single-dose prefilled syringe NDC 0069-0195-01 Fragmin ® (dalteparin sodium) Injection, USP 2,500 units/0.2 mL For Subcutaneous Use Rx only PAA233721 PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Blister Pack Label - 0195

PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Carton - 0195 NDC 0069-0195-02 Contains 10 of NDC 0069-0195-01 10 x 0.2 mL Single-dose prefilled syringes. Discard unused portion. Fragmin ® (dalteparin sodium) Injection, USP 2,500 units/0.2 mL For Subcutaneous Use Sterile Preservative Free Pfizer Hospital Rx only PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Carton - 0195

PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Label - 0196 0.2 mL NDC 0069-0196-01 Fragmin ® (dalteparin sodium) Injection, USP 5,000 units/0.2 mL For Subcutaneous Use Single-dose prefilled syringe Pfizer Labs Division of Pfizer Inc. NY, NY 10001 Rx only PAA233624 PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Label - 0196

PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Blister Pack Label - 0196 0.2 mL Single-dose prefilled syringe NDC 0069-0196-01 Fragmin ® (dalteparin sodium) Injection, USP 5,000 units/0.2 mL For Subcutaneous Use Rx only PAA233722 PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Blister Pack Label - 0196

PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Carton - 0196 NDC 0069-0196-02 Contains 10 of NDC 0069-0196-01 10 x 0.2 mL Single-dose prefilled syringes. Discard unused portion. Fragmin ® (dalteparin sodium) Injection, USP 5,000 units/0.2 mL For Subcutaneous Use Sterile Preservative Free Pfizer Hospital Rx only PRINCIPAL DISPLAY PANEL - 0.2 mL Syringe Carton - 0196

PRINCIPAL DISPLAY PANEL - 0.3 mL Syringe Label - 0206 0.3 mL NDC 0069-0206-01 Fragmin ® (dalteparin sodium) Injection, USP 7,500 units/0.3 mL For Subcutaneous Use Single-dose prefilled syringe Pfizer Labs Division of Pfizer Inc. NY, NY 10001 Rx only PAA233625 PRINCIPAL DISPLAY PANEL - 0.3 mL Syringe Label - 0206

PRINCIPAL DISPLAY PANEL - 0.3 mL Syringe Blister Pack Label - 0206 0.3 mL Single-dose prefilled syringe NDC 0069-0206-01 Fragmin ® (dalteparin sodium) Injection, USP 7,500 units/0.3 mL For Subcutaneous Use Rx only PAA233723 PRINCIPAL DISPLAY PANEL - 0.3 mL Syringe Blister Pack Label - 0206

PRINCIPAL DISPLAY PANEL - 0.3 mL Syringe Carton - 0206 NDC 0069-0206-02 Contains 10 of NDC 0069-0206-01 10 x 0.3 mL Single-dose prefilled syringes. Discard unused portion. Fragmin ® (dalteparin sodium) Injection, USP 7,500 units/0.3 mL For Subcutaneous Use Sterile Preservative Free Pfizer Hospital Rx only PRINCIPAL DISPLAY PANEL - 0.3 mL Syringe Carton - 0206

PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label - 0217 PAA233626 Fragmin ® 1 mL (dalteparin sodium) Injection, USP 10,000 units/mL For Subcutaneous Use Single-dose prefilled syringe Pfizer Labs Division of Pfizer Inc. NY, NY 10001 NDC 0069-0217-01 Rx only PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label - 0217

PRINCIPAL DISPLAY PANEL - 1 mL Syringe Blister Pack Label - 0217 1 mL Single-dose graduated syringe NDC 0069-0217-01 Fragmin ® (dalteparin sodium) Injection, USP 10,000 units/mL For Subcutaneous Use Rx only PAA233724 PRINCIPAL DISPLAY PANEL - 1 mL Syringe Blister Pack Label - 0217

PRINCIPAL DISPLAY PANEL - 1 mL Syringe Carton - 0217 NDC 0069-0217-02 Contains 10 of NDC 0069-0217-01 10 x 1 mL Single-dose graduated syringes. Discard unused portion. Fragmin ® (dalteparin sodium) Injection, USP 10,000 units/mL For Subcutaneous Use Sterile Preservative Free Pfizer Hospital Rx only PRINCIPAL DISPLAY PANEL - 1 mL Syringe Carton - 0217

PRINCIPAL DISPLAY PANEL - 0.5 mL Syringe Label - 0220 0.5 mL NDC 0069-0220-01 Fragmin ® (dalteparin sodium) Injection, USP 12,500 units/0.5 mL For… [Excerpted — this section continues on DailyMed.]

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Fragmin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Fragmin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$741K
Claims incl. refills
61
Beneficiaries
27
Spend / beneficiary
$27,443.96
Spend / claim
$12,147.33
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Pfizer Laboratories Div Pfizer Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pfizer Laboratories Div Pfizer Inc is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1645 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00069-0231-01 · Pfizer 00069-0234-20 · Pfizer →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.