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sodium chloride 9 mg/mL Injection, Solution — NDC 64253-0202-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

sodium chloride 9 mg/mL Injection, Solution — NDC 64253-202-30 (Billing 64253-0202-30)

by Medefil, Inc. · 60 SYRINGE, PLASTIC in 1 BOX / 10 mL in 1 SYRINGE, PLASTIC

This is a package of sodium chloride 9 mg/mL Injection, Solution from Medefil, Inc., marketed since Jan 2012 and currently FDA-listed. It is this product's only package size.

NDC 64253-0202-30
🏷️ FDA NDC (as labeled) 64253-202-30 billing pads the product 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 →

This page is curated, coded, and maintained by

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 64253-202-30 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
64253 labeler · 202 product · 30 package
Package marketed since
Jan 13, 2012
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6425320230 8
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Sodium Chloride (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class I · Aug 17, 2026 — Presence of particulate matter: Particulates identified as fiberglass (Baxter Healthcare Corporation) · FDA recall D-0849-2026
Class II · Apr 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0531-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0427-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0424-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0432-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0426-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64253-202-30
Product NDC 64253-202
11-digit billing NDC 64253020230
NCPDP billing unit ML — per mL (volume)
RxCUI 727820
UNII 451W47IQ8X
Application # NDA202832
SPL Set ID d1468c0f-dd4f-4d38-a84c-c1d110303965
Established class (EPC) Osmotic Laxative
Mechanism of action Osmotic Activity
Physiologic effect Increased Large Intestinal Motility; Inhibition Large Intestine Fluid/Electrolyte Absorption
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-01-13
Route INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Dosage form INJECTION, SOLUTION
Substance SODIUM CHLORIDE

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

GPI-14 79750010002018
GPI class Sodium Chloride (PF)
GCN Seq No 079459
GCN 45954
HICL code 008255
Ingredient (HICL) 0.9 % Sodium Chloride
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C1
Therapeutic class — intermediate (HIC2) Drugs Affecting Electrolyte Balance
HIC3 code C1B
Therapeutic class — specific (HIC3) Sodium/Saline Preparations
AHFS code 40:12.00.00
AHFS class Replacement Preparations
FDB label name SODIUM CHLORIDE 0.9% 10 ML SYR
FDB brand name Sodium Chloride
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 079459
  • GCN: 45954
  • GPI-14 (Medi-Span): 79750010002018
  • HICL (First Databank): 008255
  • AHFS class code: 40:12.00.00
  • RxCUI (RxNorm): 727820
Why two NDCs? The FDA registers this code as 64253-202-30 — a 5-3-2 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 product segment → 64253-0202-30. 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 Sodium class.

Drug family (ATC) Sodium, Salt solutions, Electrolyte solutions
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 SODIUM CHLORIDE 0.9% 10 ML SYR Ingredient 0.9 % Sodium Chloride
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. IV forms replace fluid and salt, while injection diluents dissolve other drugs. Other forms are used for rinsing, nasal congestion and nasal care, or to...
  • Follow the directions on your product. Many are used as often as needed by adults and children 4 and over. Do not share the bottle, because that can spread infection.
  • Some people get fever, irritation or infection at the IV site, or too much fluid in the body. Tell your nurse right away if the IV site hurts or looks red.
  • What side effects should I expect with IV sodium chloride?
📖 Read our full Sodium Chloride guide →
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 mLPer 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
64253-0202-30 You're viewing this Main listing 60 SYRINGE, PLASTIC in 1 BOX / 10 mL in 1 SYRINGE, PLASTIC 2012-01-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bacteriostatic Sodium Chloride 9 mg/mL 00409-1966-05 Hospira, 25 vials $0.067 AP Availability likely —
Sodium Chloride 9 mg/mL 00409-4888-10 Hospira, 25 vials $0.089 AP Availability likely —
sodium chloride 9 mg/mLthis 64253-0202-30 Medefil, 60 syringes — — FDA listed —
Sodium Chloride 9 mg/mL 71872-7248-01 Medical 1 vial — AP FDA listed —
Sodium Chloride 9 mg/mL 76420-0083-10 Asclemed 10 ml — AP FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mL 71872-7083-01 Medical 1 vial — AP FDA listed —
Sodium Chloride 9 mg/mL 00641-0497-25 Hikma 25 vials — — FDA listed —
Sodium Chloride 9 mg/mL 51662-1464-01 HF 20 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 55154-0126-05 Cardinal 5 vials — AP Discontinued —
Sodium Chloride 9 mg/mL 00404-9954-20 Henry 1 vial — AP FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mL 00404-9953-10 Henry 1 vial — AP FDA listed —
Sodium Chloride 9 mg/mL 84549-0888-10 ProPharma 10 ml — AP FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mL 63323-0924-10 Fresenius 25 vials — AP FDA listed —
Sodium Chloride 9 mg/mL 00641-6144-25 Hikma 25 vials — — FDA listed —
Bacteriostatic Sodium Chloride 9 mg/mL 84549-0966-07 ProPharma 30 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 65282-1505-01 Spectra 5 ampules — AP FDA listed —
Sodium Chloride 9 mg/mL 51662-1342-01 HF 10 ml — AP FDA listed —
Sodium Chloride 9 mg/mL 65282-1510-01 Spectra 5 ampules — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2012
On the market since
Jan 2012
📍
2026
Currently FDA-listed
14 years listed
🔒
·
Generic approved (availability unconfirmed)
see note
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

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.

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

  • 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.

1 inactive ingredient 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

LabelerMedefil, Inc.
Application holderMEDEFIL INC
FDA applicationNDA202832 (NDA)
Labeler code64253
First marketedJan 2012
Product typeHuman Prescription Drug
Portfolio4 products on file

More NDCs from Medefil, Inc. labeler code 64253

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. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 63 words ▾

1 INDICATIONS & USAGE Sodium Chloride Injection, USP, 0.9% is indicated for: • Dilution or Dissolving the drugs for intravenous, intramuscular or subcutaneous injections ( 1.1 ).

1.1Dilution or Dissolution of Drugs Sodium Chloride Injection, USP, 0.9% is indicated for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE & ADMINISTRATION • Volume of preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration recommended by the drug manufacturer ( 2.1 ).

2.1Recommended Dosage The volume of preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the drug manufacturer.

2.2Instruction for Administration Solution and fluid path are sterile and non-pyrogenic if the tip cap is in place, syringe is intact and there is no evidence of leakage. Use proper aseptic technique. Inspect plastic wrapping.

Do not use if plastic wrapping is damaged or not intact. (Figure 1) Remove plastic packaging by tearing along perforation. (Figure 2) Do not use if, solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged.

(Figure 3) With the tip cap of the syringe on, press the syringe forward to properly activate the syringe. Improper activation may difficult syringe use and/or may cause plunger rod separation. Never draw back rod because the product may become contaminated.

(Figure 4) Remove tip cap. Hold the syringe unit upright and prime to expel any air bubble if present. (Figure 5) Syringe is now ready to use.

Use aseptic techniques for diluting or dissolving drugs, mix thoroughly and use according to the drug manufacturer’s label instructions. Discard empty unit after use. Discard any unused portion.

Do not reuse disposable syringes.

2.3Preparation and Handling Precautions Before use check for any possible incompatibility with sodium chloride. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not administer unless solution is clear and seal is intact.

Do not store reconstituted solution or drugs for injection unless otherwise directed by the manufacturer of the solute. Adding additives may be incompatible. Do not use if, solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged.

Do not freeze. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

2.2Instruction for Administration Solution and fluid path are sterile and non-pyrogenic if the tip cap is in place, syringe is intact and there is no evidence of leakage. Use proper aseptic technique. Inspect plastic wrapping.

Do not use if plastic wrapping is damaged or not intact. (Figure 1) Remove plastic packaging by tearing along perforation. (Figure 2) Do not use if, solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged.

(Figure 3) With the tip cap of the syringe on, press the syringe forward to properly activate the syringe. Improper activation may difficult syringe use and/or may cause plunger rod separation. Never draw back rod because the product may become contaminated.

(Figure 4) Remove tip cap. Hold the syringe unit upright and prime to expel any air bubble if present. (Figure 5) Syringe is now ready to use.

Use aseptic techniques for diluting or dissolving drugs, mix thoroughly and use according to the drug manufacturer’s label instructions. Discard empty unit after use. Discard any unused portion.

Do not reuse disposable syringes.

💊 Dosage Forms and Strengths 21 words ▾

3 DOSAGE FORMS & STRENGTHS 10 mL fill in 12 mL syringe, 0.9% Sodium Chloride, USP, single use. • Injection, 0.9%

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None • None

⚠️ Warnings and Cautions 191 words ▾

5 WARNINGS AND PRECAUTIONS • Consult the drug product manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving drugs to be injected including the route and rate of injection ( 5.1 ). • Do not use Sodium Chloride Injection, USP, 0.9% if the solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged ( 5.1 ). • For single use only. Discard unused portion ( 5.2 ).

5.1General When used to dilute drug products, consult the drug product manufacturer’s instructions for choice of vehicle, appropriate dilution or volume for dissolving drugs to be injected including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Do not use Sodium Chloride Injection, USP 0.9% if the solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe is damaged.

5.2For Single Use Only Re-use of single-use product creates a potential risk to the user. Contamination of product and/or limited functionality of the syringe may lead to injury, illness or death. Discard any unused portion.

🤒 Adverse Reactions 155 words ▾

6 ADVERSE REACTIONS Adverse reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include, but are not limited to, air embolization, febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and if possible, retrieve and save the remainder of unused vehicle for examination if deemed necessary. • Reactions that may occur because of this solution, added drugs or the technique of reconstitution or administration include air embolization, febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasations ( 6 ).

To report SUSPECTED ADVERSE REACTIONS, contact MEDEFIL, INC. at tel:1-630-682-4600 and http://www.medefilinc.com/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions 86 words ▾

7 DRUG INTERACTIONS Some drugs or injections may be incompatible when combined with 0.9% sodium chloride. Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, the drug product manufacturer’s instructions or other specific references should be checked for any possible incompatibility with sodium chloride. Consult with a pharmacist, if unsure of compatibility. • Some drugs or injections may be incompatible when combined with 0.9% sodium chloride. • Consult with a pharmacist, if unsure of compatibility ( 7 ).

🧬 Clinical Pharmacology 90 words ▾

12 CLINICAL PHARMACOLOGY Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl-) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. The small volume of fluid and amount of sodium chloride provided by Sodium Chloride Injection, USP, 0.9% when used only as an isotonic vehicle for parenteral injection of drugs or for flushing of indwelling access devices, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants.

📦 How Supplied / Storage and Handling 110 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING The drug product is packaged in a clear plastic hypodermic syringe, which consists of a hypodermic barrel with luer lock, plunger stopper, plunger rod, and tip cap. The syringe is intended for single use and subsequent disposal. The 10 mL fill volume syringes are packaged individually in plastic pouches and 60 syringes are packaged into each dispensing box.

DOSAGE FORM Product Number NDC Fill Volume MSD-0230 64253-202-30 10 mL fill in 12 mL syringe The above product is available in boxes of 30, 60 or 120 count each. STORAGE AND HANDLING Store at 25°C (77°F); excursions permitted to 15°-30°C (59° - 86°F). Do not freeze.

📋 Description 147 words ▾

11 DESCRIPTION Sodium Chloride Injection, USP 0.9% is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. It contains no bacteriostatic antimicrobial agents or added buffer. The nominal pH is 5.5 (4.5 to 7.0).

Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment. Sodium Chloride Injection, USP, 0.9% contains 9 g/L Sodium Chloride, USP (NaCl) with a calculated osmolarity of approximately 308 mOsmol/L. It contains 154 mEq/L sodium and 154 mEq/L chloride.

The syringe component of Sodium Chloride Injection, USP, 0.9% is manufactured with polypropylene and luer lock. The syringe is not made with natural rubber latex. The syringe is not made with DEHP.

This product contains no preservative. The syringes require no vapor barrier to maintain the proper drug concentration. The empirical formula for sodium chloride is NaCl and the molecular weight is 58.44 g/mol.

Supplied as single use syringes.

💬 Information for Patients 128 words ▾

17 PATIENT COUNSELING INFORMATION

17.1When using to dilute drug products, consult the drug product manufacturer’s instruction to confirm compatibility, appropriate dilution or volume for dissolving drugs including the route and rate of injection. Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration. Do not use Sodium Chloride Injection, USP 0.9% if the solution is discolored, cloudy, hazy, or contains a precipitate, or if the syringe damaged [ see Warning and Precautions, section 5.1 ].

17.2Syringes are for single use only. Discard unused portions and dispose of the unit in an appropriate sharps container. [ see Warning and Precaustions, section 5.2 ]. Medefil, Inc., 250 Windy Point Drive, Glendale Heights, IL 60139. Prepared 10/2020 Rev. 003

📄 Package Label / Principal Display Panel 29 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Manufactured by: Medefil, Inc., 250 Windy Point Drive, Glendale Heights, IL 60139. NDA 202832 Rev. 003 syringe-label box-label

Package Insert_Page 1 and 2 l4061r004page2 l4061r004page1

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 Sodium Chloride — the program that covers self-administered drugs. 9 manufacturers.
⚠️ 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 Sodium Chloride. 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
$2.42M
Claims incl. refills
105K
Beneficiaries
50.3K
Spend / beneficiary
$48.15
Spend / claim
$23.08
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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 Medefil, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medefil, 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.
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.
← 64253-0020-21 · Medefil, 64253-0400-91 · Medefil, →
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.