Home › NDC Lookup › Ingredients › Propofol › 63323-0269-65
Diprivan PROPOFOL 10 mg/mL Injection, Emulsion — NDC 63323-0269-65 package photo

Diprivan PROPOFOL 10 mg/mL Injection, Emulsion

by Fresenius Kabi USA, LLC · 10 VIAL in 1 BOX (63323-269-65) / 100 mL in 1 VIAL (63323-269-35)
NDC 63323-0269-65
🏷️ FDA NDC (as labeled) 63323-269-65 billing pads the product segment with a zero
This package
Contains100 mL in 1 vial Medicaid pays$1.12 / unit · 12 mo Per package$1,122.30 / 1000 ml · Medicaid Pack sizes14 compare ↓
Also comes in: 10 vials 63323-0269-69 10 vials 63323-0269-94 10 vials 63323-0269-10 10 vials 63323-0269-29 10 vials 63323-0269-70 10 vials 63323-0269-78 10 vials 63323-0269-16 10 vials 63323-0269-37 10 vials 63323-0269-67 20 vials 63323-0269-59 20 vials 63323-0269-50 20 vials 63323-0269-77 20 vials 63323-0269-57
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 17, 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

Past resolved recalls for this product (2)
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1115-2022
Class II · Apr 13, 2022 · Terminated — cGMP deviations: Temperature abuse (Mckesson Medical-Surgical Inc. Corporate Office) · FDA recall D-1116-2022

🆔 Identity & classification

FDA NDC (as labeled) 63323-269-65
Product NDC 63323-269
11-digit billing NDC 63323026965
NCPDP billing unit ML — per mL (volume)
RxCUI 1808217, 1808219, 1808222, 1808223, 1808224, 1808225, 1808234, 1808235
UNII YI7VU623SF
UPC 0363323269302, 0363323269357, 0363323269012, 0363323269227
Application # NDA019627
SPL Set ID d1ae9e26-ffd6-43df-bbd6-869cdede6afe
Established class (EPC) General Anesthetic
Physiologic effect General Anesthesia
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-11-13
Route INTRAVENOUS
Dosage form INJECTION, EMULSION
Substance PROPOFOL
GPI-14 70400050001640
GPI class Diprivan
GCN Seq No 016796
GCN 14021
HICL code 004842
Ingredient (HICL) Propofol In Lipid Emulsions
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H2
Therapeutic class — intermediate (HIC2) Psychoactive Drugs
HIC3 code H2C
Therapeutic class — specific (HIC3) General Anesthetics,Injectable
AHFS code 28:04.08.00
AHFS class Non-Barbiturates
FDB label name DIPRIVAN 1,000 MG/100 ML VIAL
FDB brand name Diprivan
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 63323-269-65 — 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 → 63323-0269-65. 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 General Anesthetic class.

Pharmacologic class General Anesthetic
Drug family (ATC) Other general anesthetics
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.

🏭 Manufacturer & labeler

LabelerFresenius Kabi USA, LLC
Application holderFRESENIUS KABI USA LLC
FDA applicationNDA019627 (NDA)
Labeler code63323
First marketedNov 2009
Product typeHuman Prescription Drug
Portfolio554 products on file
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.

🩺 Clinical

Label name DIPRIVAN 1,000 MG/100 ML VIAL Ingredient Propofol In Lipid Emulsions
📗 Our plain-language guide HelloPharmacist
  • Propofol is a fast-acting anesthetic and sedation drug given through an IV. Most commonly, you'd receive it to put you to sleep and keep you comfortable during surgery, or to keep...
  • What exactly is propofol used for? Why am I getting it?
  • Most people don't feel much more than a brief burning or stinging sensation in the vein where it's injected — that's one of the more common things patients notice. Within seconds y...
  • Will I feel anything when it's given? Will I remember anything?
📖 Read our full Propofol guide →
1
Nutrient depletion considerations

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

🧪 Full Propofol 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.

🧪 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 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • 12 mg / 1 mL UNII 1Z74184RGV
    Egg phospholipids are naturally derived fats from eggs that help mix oil and water-based ingredients together. They work as emulsifiers in medicines, keeping the formula stable and uniform.
  • 22.5 mg / 1 mL UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 100 mg / 1 mL UNII 241ATL177A
    Soybean oil is a natural plant oil derived from soybean seeds. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients and improve how the body absorbs them.

5 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.

💲 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 $1.12 $1,122.30 / 1000 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J3490 No ASP payment limit on file for J3490 this quarter.
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)63323-269-65
11-digit billing NDC63323-0269-65
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ3490
DescriptorUNCLASSIFIED DRUGS
Billing units / pkg1 units
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
propofol 10 mg/mL 71288-0730-51 Meitheal 10 vials $0.171 AB Availability likely —
Propofol 10 mg/mL 00409-6010-25 Hospira, 25 vials $0.171 AB Availability likely —
propofol 10 mg/mL 25021-0608-20 Sagent 25 vials $0.171 AB Availability likely —
Propofol 10 mg/mL 00409-1511-98 Hospira, 25 vials $0.171 AB Availability likely —
Propofol 10 mg/mL 00641-6194-10 Hikma 10 vials — AB FDA listed —
Propofol 10 mg/mL 00641-6195-20 Hikma 20 vials — AB FDA listed —
Propofol 10 mg/mL 00641-6196-10 Hikma 10 vials — AB FDA listed —
Propofol 10 mg/mL 51662-1293-01 HF 20 ml — AB FDA listed —
Propofol 10 mg/mL 00069-0234-20 Pfizer 20 vials — AB FDA listed —
propofol 10 mg/mL 16714-0690-10 NorthStar 10 vials — AB FDA listed —
Propofol 10 mg/mL 51662-1471-01 HF 50 ml — AB FDA listed —
Propofol 10 mg/mL 00069-0209-10 Pfizer 10 vials — AB FDA listed —
Propofol 10 mg/mL 72572-0590-10 Civica, 10 vials — AB FDA listed —
Propofol 10 mg/mL 51662-1470-01 HF 100 ml — AB FDA listed —
Diprivan 10 mg/mLthis 63323-0269-65 Fresenius 10 vials — AB FDA listed —
propofol 10 mg/mL 71288-0729-21 Meitheal 10 vials — AB FDA listed —
Propofol 10 mg/mL 00409-4699-24 Hospira, 10 vials — AB FDA listed —
Propofol 10 mg/mL 80830-2364-08 Amneal 20 vials — AB FDA listed —
Propofol 10 mg/mL 80830-2365-07 Amneal 10 vials — AB FDA listed —
propofol 10 mg/mL 23155-0345-41 Heritage 10 vials — AB FDA listed —
Diprivan 10 mg/mL 65219-0800-10 Fresenius 10 vials — AB FDA listed —
Propofol 10 mg/mL 72572-0612-10 Civica, 10 vials — AB FDA listed —
Propofol 10 mg/mL 80830-1188-07 Amneal 10 vials — AB FDA listed —
Propofol 10 mg/mL 00069-0248-10 Pfizer 10 vials — AB FDA listed —
propofol 10 mg/mL 16714-0977-20 NorthStar 20 vials — AB FDA listed —
Propofol 10 mg/mL 72572-0601-20 Civica, 20 vials — AB FDA listed —
propofol 10 mg/mL 16714-0528-10 NorthStar 10 vials — AB FDA listed —
Propofol 10 mg/mL 83634-0603-20 Avenacy, 20 vials — AB FDA listed —
propofol 10 mg/mL 71288-0731-53 Meitheal 10 vials — AB FDA listed —
Propofol 10 mg/mL 83854-0018-10 Anthea 10 vials — AB FDA listed —
Propofol 10 mg/mL 00409-0501-98 Hospira, 20 vials — AB FDA listed —
Propofol 10 mg/mL 00409-0010-98 Hospira, 10 vials — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
2009
On the market since
Nov 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 63323-0269-65, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
26.6K
Units reimbursed last 4 qtrs
3M
Gross reimbursed last 4 qtrs
$3.35M
Avg / prescription
$125.66
Avg / unit
$1.1223
Latest quarter Q4 2025
4.4KRx
Fee-for-service vs managed care ⓘ
13% FFS 87% MCO
Fee-for-service · 3,498 Rx Managed care · 23,123 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 3,785 units · 48.5 per 100k residents WA Idaho: 95,500 units · 4,863 per 100k residents ID Montana: 6,036 units · 533 per 100k residents MT North Dakota: 38,300 units · 4,891 per 100k residents ND Minnesota: 137,181 units · 2,391 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 167,790 units · 857 per 100k residents NY Vermont: 1,365 units · 211 per 100k residents VT New Hampshire: 32,933 units · 2,349 per 100k residents NH Oregon: 21,207 units · 501 per 100k residents OR Nevada: 1,813 units · 56.8 per 100k residents NV Wyoming: no data reported WY South Dakota: 27,003 units · 2,938 per 100k residents SD Iowa: 31,999 units · 998 per 100k residents IA Illinois: no data reported IL Indiana: 1,700 units · 24.8 per 100k residents IN Ohio: 135,914 units · 1,153 per 100k residents OH Pennsylvania: 171,061 units · 1,320 per 100k residents PA New Jersey: 128,355 units · 1,382 per 100k residents NJ Massachusetts: 36,556 units · 522 per 100k residents MA California: 253,775 units · 651 per 100k residents CA Utah: 292 units · 8.5 per 100k residents UT Colorado: 7,440 units · 127 per 100k residents CO Nebraska: 8,620 units · 436 per 100k residents NE Missouri: 54,201 units · 875 per 100k residents MO Kentucky: 48,524 units · 1,072 per 100k residents KY West Virginia: 6,310 units · 356 per 100k residents WV Virginia: 53,194 units · 610 per 100k residents VA Maryland: 9,402 units · 152 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 43,500 units · 2,058 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 84,843 units · 1,191 per 100k residents TN North Carolina: 148,435 units · 1,370 per 100k residents NC South Carolina: no data reported SC Delaware: 163,402 units · 15,849 per 100k residents DE Oklahoma: no data reported OK Louisiana: 5,599 units · 122 per 100k residents LA Mississippi: 4,809 units · 164 per 100k residents MS Alabama: no data reported AL Georgia: 6,803 units · 61.7 per 100k residents GA D.C.: 3,626 units · 534 per 100k residents DC Hawaii: 1,023,547 units · 71,327 per 100k residents HI Texas: no data reported TX Florida: 15,757 units · 69.7 per 100k residents FL
Units reimbursed · per 100k residents
8.571,327
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Hawaii 71,327 /100k
2 Delaware 15,849 /100k
3 North Dakota 4,891 /100k
4 Idaho 4,863 /100k
5 South Dakota 2,938 /100k
6 Minnesota 2,391 /100k
7 New Hampshire 2,349 /100k
8 New Mexico 2,058 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 vials63323-0269-29 155,649 Rx · $20,420,969
10 vials63323-0269-37 42,763 Rx · $3,894,203
10 vials63323-0269-70 40,790 Rx · $2,481,356
10 vials63323-0269-94 30,145 Rx · $2,680,678
20 vials63323-0269-50 27,316 Rx · $3,783,720
10 vials this page63323-0269-65 26,621 Rx · $3,345,141
10 vials63323-0269-67 8,040 Rx · $1,662,833
20 vials63323-0269-57 7,646 Rx · $1,668,833
10 vials63323-0269-10 5,049 Rx · $852,293
10 vials63323-0269-69 4,694 Rx · $919,030
20 vials63323-0269-59 3,950 Rx · $216,733
20 vials63323-0269-77 3,139 Rx · $192,739
10 vials63323-0269-78 2,814 Rx · $227,183
10 vials63323-0269-16 1,264 Rx · $1,304
Drug total (last 4 qtrs): 359,880 Rx · 12,857,003 units · $42,347,014 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63323-0269-59 20 VIAL in 1 BOX (63323-269-59) / 50 mL in 1 VIAL (63323-269-45) 2009-11-13 Active
63323-0269-69 10 VIAL in 1 BOX (63323-269-69) / 100 mL in 1 VIAL (63323-269-41) 2009-11-13 Active
63323-0269-94 10 VIAL in 1 BOX (63323-269-94) / 20 mL in 1 VIAL (63323-269-43) 2009-11-13 Active
63323-0269-10 10 VIAL in 1 BOX (63323-269-10) / 10 mL in 1 VIAL 2009-11-13 Active
63323-0269-29 10 VIAL in 1 BOX (63323-269-29) / 20 mL in 1 VIAL (63323-269-22) 2009-11-13 Active
63323-0269-50 20 VIAL in 1 BOX (63323-269-50) / 50 mL in 1 VIAL (63323-269-30) 2009-11-13 Active
63323-0269-65 You're viewing this 10 VIAL in 1 BOX (63323-269-65) / 100 mL in 1 VIAL (63323-269-35) 2009-11-13 Active
63323-0269-70 10 VIAL in 1 BOX (63323-269-70) / 20 mL in 1 VIAL (63323-269-33) 2009-11-13 Active
63323-0269-77 20 VIAL in 1 BOX (63323-269-77) / 50 mL in 1 VIAL (63323-269-75) 2009-11-13 Active
63323-0269-78 10 VIAL in 1 BOX (63323-269-78) / 100 mL in 1 VIAL (63323-269-31) 2009-11-13 Active
63323-0269-16 10 VIAL in 1 BOX (63323-269-16) / 10 mL in 1 VIAL (63323-269-06) 2009-11-17 Active
63323-0269-37 10 VIAL in 1 BOX (63323-269-37) / 20 mL in 1 VIAL (63323-269-25) 2009-11-17 Active
63323-0269-57 20 VIAL in 1 BOX (63323-269-57) / 50 mL in 1 VIAL (63323-269-23) 2009-11-17 Active
63323-0269-67 10 VIAL in 1 BOX (63323-269-67) / 100 mL in 1 VIAL (63323-269-21) 2009-11-17 Active

This pack accounts for about 7.4% of this product's recent Medicaid fills; the largest share goes to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 63323-0269-65?
NDC 63323-0269-65 is listed by the FDA — 10 vial in 1 box / 100 ml in 1 vial.
What NDC number is used to bill for this package of Diprivan PROPOFOL 10 mg/mL Injection, Emulsion?
Bill NDC 63323-0269-65 — the 11-digit billing format is 63323026965. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 FDA registers it as 63323-269-65, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63323-0269-65, written without dashes as 63323026965. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63323-0269-65, the first segment (63323) is the labeler code FDA assigned to Fresenius Kabi USA, LLC; the middle segment (0269) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (65) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Fresenius Kabi USA, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 13 other package presentations of this same product, including 10 vials (63323-0269-69), 10 vials (63323-0269-94), 10 vials (63323-0269-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Fresenius Kabi USA, LLC 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 J3490 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.

📄 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 👥 Use in Specific Populations 🤰 Pregnancy 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE DIPRIVAN is an intravenous general anesthetic and sedation drug indicated for: • Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age • Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age • Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients • Sedation for Adult Patients in Combination with Regional Anesthesia • Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients Limitations of Use DIPRIVAN is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use ( 8.4 )] .

Safety, effectiveness and dosing guidelines for DIPRIVAN have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediatric Use ( 8.4 )]. DIPRIVAN is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use ( 8.4 )]. DIPRIVAN is an intravenous general anesthetic and sedation drug indicated for: • Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age • Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age • Initiation and Maintenance of Monitored Anesthesia Care (MAC) • Sedation in Adult Patients Sedation for Adult Patients in Combination with Regional Anesthesia • Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients Limitations of Use : DIPRIVAN is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months.

MAC sedation in the pediatric population is not recommended. DIPRIVAN is not indicated for use in Pediatric ICU sedation.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION See Full Prescribing Information for detailed dosing instructions.

2.1Important Dosage and Administration Information Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Shake well before use. Do not use if there is evidence of excessive creaming or aggregation, if large droplets are visible, or if there are other forms of phase separation indicating that the stability of the product has been compromised.

Slight creaming, which should disappear after shaking, may be visible upon prolonged standing. Do not use if there is evidence of separation of the phases of the emulsion. DIPRIVAN with EDTA inhibits microbial growth for up to 12 hours, as demonstrated by test data for representative USP microorganisms.

Product is packaged under nitrogen. For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure. Sedated patients should be continuously monitored, and equipment for maintaining a patent airway, providing artificial ventilation, administering supplemental oxygen, and instituting cardiovascular resuscitation must be immediately available.

Patients should be continuously monitored for early signs of hypotension, apnea, airway obstruction, and/or oxygen desaturation. These cardiorespiratory effects are more likely to occur following rapid bolus administration, especially in the elderly, debilitated, or ASA-PS III or IV patients. For sedation of intubated, mechanically ventilated adult patients in the Intensive Care Unit, DIPRIVAN should be administered only by persons skilled in the management of critically ill patients and trained in cardiovascular resuscitation and airway management.

Guidelines for Aseptic Technique for General Anesthesia/MAC Sedation DIPRIVAN must be prepared for use just prior to initiation of each individual anesthetic/sedative procedure. The vial rubber stopper should be disinfected using 70% isopropyl alcohol. DIPRIVAN should be drawn into a sterile syringe immediately after a vial is opened.

When withdrawing DIPRIVAN from vials, a sterile vent spike should be used. The syringe should be labelled with appropriate information including the date and time the vial was opened. Administration should commence promptly and be completed within 12 hours after the vial has been opened.

DIPRIVAN must be prepared for single dose only. Any unused DIPRIVAN drug product, reservoirs, dedicated administration tubing and/or solutions containing DIPRIVAN must be discarded at the end of the anesthetic procedure or at 12 hours, whichever occurs sooner. The intravenous line should be flushed every 12 hours and at the end of the anesthetic procedure to remove residual DIPRIVAN. [see Warnings and Precautions ( 5.2 )] .

Guidelines for Aseptic Technique for ICU Sedation DIPRIVAN must be prepared for single dose only. Strict aseptic techniques must be followed. The vial rubber stopper should be disinfected using 70% isopropyl alcohol.

A sterile vent spike and sterile tubing must be used for administration of DIPRIVAN. As with other lipid emulsions, the number of intravenous line manipulations should be minimized. Administration should commence promptly and must be completed within 12 hours after the vial has been spiked.

The tubing and any unused DIPRIVAN drug product must be discarded after 12 hours. If DIPRIVAN is transferred to a syringe prior to administration, it should be drawn into a sterile syringe immediately after a vial is opened. When withdrawing DIPRIVAN from a vial, a sterile vent spike should be used.

The syringe should be labelled with appropriate information including the date and time the vial was opened. Administration should commence promptly and be completed within 12 hours after the vial has been opened.…

💊 Dosage Forms and Strengths 101 words ▾

3 DOSAGE FORMS AND STRENGTHS DIPRIVAN ® (propofol) injectable emulsion, USP is available in single-dose vials as follows: 200 mg of propofol per 20 mL of an oil-in-water emulsion (10 mg per mL), 20 mL vial 500 mg of propofol per 50 mL of an oil-in-water emulsion (10 mg per mL), 50 mL vial 1,000 mg of propofol per 100 mL of an oil-in-water emulsion (10 mg per mL), 100 mL vial Injectable emulsion: 200 mg per 20 mL (10 mg/mL), 500 mg per 50 mL (10 mg/mL), and 1,000 mg per 100 mL (10 mg/mL) single-dose vials ( 3 )

⛔ Contraindications 46 words ▾

4 CONTRAINDICATIONS DIPRIVAN is contraindicated in patients with a known hypersensitivity to propofol or any of DIPRIVAN components. DIPRIVAN is contraindicated in patients with a history of anaphylaxis to eggs, egg products, soybeans or soy products. Known hypersensitivity to propofol, egg or soybean. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Serious and sometimes fatal reactions. ( 5.1 ) Microbial Contamination : Strict aseptic technique must be maintained during handling. DIPRIVAN vials are never to be accessed more than once or used on more than one person.

Administration should commence promptly and be completed within 12 hours after the vial has been opened. Discard unused drug product. Do not use if contamination is suspected.

( 5.2 ) Cardiovascular depression : Cases of bradycardia, asystole, and cardiac arrest have been reported. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly. ( 5.4 )

5.1Anaphylactic and Anaphylactoid Reactions Use of DIPRIVAN has been associated with both fatal and life threatening anaphylactic and anaphylactoid reactions. Clinical features of anaphylaxis, including angioedema, bronchospasm, erythema, and hypotension, occur rarely following DIPRIVAN administration.

5.2Risks of Microbial Contamination Strict aseptic technique must always be maintained during handling. DIPRIVAN is a single-dose parenteral product (single patient infusion vial) which contains 0.005% disodium edetate (EDTA) to inhibit the rate of growth of microorganisms, for up to 12 hours, in the event of accidental extrinsic contamination. However, DIPRIVAN can still support the growth of microorganisms, as it is not an antimicrobially preserved product under USP standards.

Do not use if contamination is suspected. Discard unused drug product as directed within the required time limits. There have been reports in which failure to use aseptic technique when handling DIPRIVAN was associated with microbial contamination of the product and with fever, infection/sepsis, other life-threatening illness, and/or death.

DIPRIVAN vials are never to be accessed more than once or used on more than one person. There have been reports, in the literature and other public sources, of the transmission of bloodborne pathogens (such as Hepatitis B, Hepatitis C, and HIV) from unsafe injection practices, and of the use of propofol vials intended for single use on multiple persons.

5.3Risks of Pediatric Neurotoxicity Published animal studies demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity increase neuronal apoptosis in the developing brain and result in long-term cognitive deficits when used for longer than 3 hours. The clinical significance of these findings is not clear. However, based on the available data, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester of gestation through the first several months of life, but may extend out to approximately three years of age in humans [see Animal Toxicology and/or Pharmacology ( 13.2 )].

Some published studies in children suggest that similar deficits may occur after repeated or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects. These studies have substantial limitations, and it is not clear if the observed effects are due to the anesthetic/sedation drug administration or other factors such as the surgery or underlying illness. Anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other.

Decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks.

5.4Risks of Bradycardia, Asystole, and Cardiac Arrest DIPRIVAN has no vagolytic activity. Reports of bradycardia, asystole, and rarely, cardiac arrest have been associated with DIPRIVAN. Pediatric patients are susceptible to this effect, particularly when fentanyl is given concomitantly. The intravenous administration of anticholinergic a…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious or otherwise important adverse reactions are discussed elsewhere in the labeling: • Hypersensitivity reaction [see Warnings and Precautions ( 5.1 )] • Hypotension and/or bradycardia [see Warnings and Precautions ( 5.4 )] • Propofol Infusion Syndrome [see Warnings and Precautions ( 5.9 )] In the description below, rates of the more common events represent US/Canadian clinical study results. Less frequent events are also derived from publications and marketing experience in over 8 million patients; there are insufficient data to support an accurate estimate of their incidence rates.

These studies were conducted using a variety of premedicants, varying lengths of surgical/diagnostic procedures, and various other anesthetic/sedative agents. Most adverse events were mild and transient. Clinical 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 reflect the rates observed in practice.

Anesthesia and MAC Sedation in Adults The following estimates of adverse events for DIPRIVAN include data from clinical trials in general anesthesia/MAC sedation (N=2889 adult patients). The adverse events listed below as probably causally related are those events in which the actual incidence rate in patients treated with DIPRIVAN was greater than the comparator incidence rate in these trials. Therefore, incidence rates for anesthesia and MAC sedation in adults generally represent estimates of the percentage of clinical trial patients which appeared to have probable causal relationship.

The adverse experience profile from reports of 150 patients in the MAC sedation clinical trials is similar to the profile established with DIPRIVAN during anesthesia (see Table 3 below). During MAC sedation clinical trials, significant respiratory events included cough, upper airway obstruction, apnea, hypoventilation, and dyspnea. Anesthesia in Pediatric Patients Generally, the adverse experience profile from reports of 506 DIPRIVAN pediatric patients from 6 days through 16 years of age in the US/Canadian anesthesia clinical trials is similar to the profile established with DIPRIVAN during anesthesia in adults.

Although not reported as an adverse event in clinical trials, apnea is frequently observed in pediatric patients. ICU Sedation in Adults The following estimates of adverse events include data from clinical trials in ICU sedation (N=159 adult patients). Probably related incidence rates for ICU sedation were determined by individual case report form review.

Probable causality was based upon an apparent dose response relationship and/or positive responses to rechallenge. In many instances the presence of concomitant disease and concomitant therapy made the causal relationship unknown. Therefore, incidence rates for ICU sedation generally represent estimates of the percentage of clinical trial patients which appeared to have a probable causal relationship.

Table 2. Treatment Emergent Adverse Events Observed from Clinical Trials Anesthesia/MAC Sedation ICU Sedation Body as a Whole: Anaphylaxis/Anaphylactoid reaction perinatal disorder, tachycardia, bigeminy, bradycardia, premature ventricular contractions, hemorrhage, ECG abnormal arrhythmia atrial, fever, extremities pain, anticholinergic syndrome, asthenia, awareness, chest pain, extremities pain, fever, increased drug effect, neck rigidity/stiffness, trunk pain Fever, sepsis, trunk pain, whole body weakness Cardiovascular: Premature atrial contractions Syncope, hypotension [see also Clinical Pharmacology ( 12 )], t achycardia Nodal, arrhythmia Bradycardia, arrhythmia, atrial fibrillation, atrioventricular heart block, bigeminy, bleeding, bundle branch block, cardiac arrest, ECG abnormal, edema, extrasystole, heart block, hypertension, myocardial infarction, myocardial ischemia, premat…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Opioids and Sedatives The induction dose requirements of DIPRIVAN may be reduced in patients with intramuscular or intravenous premedication, particularly with opioids (e.g., morphine, meperidine, and fentanyl, etc.) and combinations of opioids and sedatives (e.g., benzodiazepines, barbiturates, chloral hydrate, droperidol, etc.). These agents may increase the anesthetic or sedative effects of DIPRIVAN and may also result in more pronounced decreases in systolic, diastolic, and mean arterial pressures and cardiac output.

In pediatric patients, administration of fentanyl concomitantly with DIPRIVAN may result in serious bradycardia. Analgesic Agents During maintenance of anesthesia or sedation, the rate of DIPRIVAN administration should be adjusted according to the desired level of anesthesia or sedation and may be reduced in the presence of supplemental analgesic agents (e.g., nitrous oxide or opioids). The concurrent administration of potent inhalational agents (e.g., isoflurane, sevoflurane, desflurane, enflurane, and halothane) during maintenance with DIPRIVAN are routinely used.

These inhalational agents can also be expected to increase the anesthetic or sedative and cardiorespiratory effects of DIPRIVAN. Valproate The concomitant use of valproate and propofol may lead to increased blood levels of propofol. Reduce the dose of propofol when co-administering with valproate.

Monitor patients closely for signs of increased sedation or cardiorespiratory depression. Common Neuromuscular Blocking Agents DIPRIVAN does not cause a clinically significant change in onset, intensity or duration of action of the commonly used neuromuscular blocking agents (e.g., succinylcholine and nondepolarizing muscle relaxants). Common Drugs Used as Premedication or Drugs Used During Anesthesia or Sedation No significant adverse interactions with commonly used premedications or drugs used during anesthesia or sedation (including a range of muscle relaxants, inhalational agents, analgesic agents, and local anesthetic agents) have been observed in adults.

Opioids, Sedatives or Other Analgesic Agents : May increase the anesthetic/sedative and cardiorespiratory effects. ( 7 ) Valproate : May lead to increased blood levels of propofol. ( 7 )

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Data from randomized controlled trials, cohort studies and case series over several decades with propofol use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Most of the reported exposures to propofol describe propofol exposure at the time of cesarean delivery. There are reports of neonatal depression in infants exposed to propofol during delivery (see Clinical Considerations ).

In animal reproduction studies, decreased pup survival concurrent with increased maternal mortality was observed with intravenous administration of propofol to pregnant rats either prior to mating and during early gestation or during late gestation and early lactation at exposures less than the human induction dose of 2.5 mg/kg. In pregnant rats administered 15 mg/kg/day intravenous propofol (equivalent to the human induction dose) from two weeks prior to mating to early in gestation (Gestation Day 7), offspring that were allowed to mate had increased postimplantation losses.

The pharmacological activity (anesthesia) of the drug on the mother is probably responsible for the adverse effects seen in the offspring. Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans [see Data , Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.4 )]).

The clinical significance of these nonclinical findings is not known, and the benefits of appropriate anesthesia in pregnant women who require procedures should be balanced with the potential risks suggested by the nonclinical data. 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 2–4% and 15–20%, respectively. Clinical Considerations Fetal/neonatal Adverse Reactions DIPRIVAN crosses the placenta and may be associated with neonatal depression. Monitor neonates for hypotonia and sedation following maternal exposure to propofol.

Data Animal Data Pregnant rats were administered propofol intravenously at 0, 5, 10, and 15 mg/kg/day (0.3, 0.65, and 1 times the human induction dose of 2.5 mg/kg based on body surface area) during organogenesis (Gestational Days 6–15). Propofol did not cause adverse effects to the fetus at exposures up to 1 times the human induction dose despite evidence of maternal toxicity (decreased weight gain in all groups). Pregnant rabbits were administered propofol intravenously at 0, 5, 10, and 15 mg/kg/day (0.65, 1.3, 2 times the human induction dose of 2.5 mg/kg based on body surface area comparison) during organogenesis (Gestation Days 6–18).

Propofol treatment decreased total numbers of corpora lutea in all treatment groups but did not cause fetal malformations at any dose despite maternal toxicity (one maternal death from anesthesia-related respiratory depression in the high dose group). Pregnant rats were administered propofol intravenously at 0, 10, and 15 mg/kg/day (0.65 and 1 times the human induction dose of 2.5 mg/kg based on body surface area) from late gestation through lactation (Gestation Day 16 to Lactation Day 22). Decreased pup survival was noted at all doses in the presence of maternal toxicity (deaths from anesthesia- induced respiratory depression).

This study did not evaluate neurobehavioral function including learning and memory in the pups. Pregnant rats were administe…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Data from randomized controlled trials, cohort studies and case series over several decades with propofol use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Most of the reported exposures to propofol describe propofol exposure at the time of cesarean delivery. There are reports of neonatal depression in infants exposed to propofol during delivery (see Clinical Considerations ).

In animal reproduction studies, decreased pup survival concurrent with increased maternal mortality was observed with intravenous administration of propofol to pregnant rats either prior to mating and during early gestation or during late gestation and early lactation at exposures less than the human induction dose of 2.5 mg/kg. In pregnant rats administered 15 mg/kg/day intravenous propofol (equivalent to the human induction dose) from two weeks prior to mating to early in gestation (Gestation Day 7), offspring that were allowed to mate had increased postimplantation losses.

The pharmacological activity (anesthesia) of the drug on the mother is probably responsible for the adverse effects seen in the offspring. Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans [see Data , Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.4 )]).

The clinical significance of these nonclinical findings is not known, and the benefits of appropriate anesthesia in pregnant women who require procedures should be balanced with the potential risks suggested by the nonclinical data. 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 2–4% and 15–20%, respectively. Clinical Considerations Fetal/neonatal Adverse Reactions DIPRIVAN crosses the placenta and may be associated with neonatal depression. Monitor neonates for hypotonia and sedation following maternal exposure to propofol.

Data Animal Data Pregnant rats were administered propofol intravenously at 0, 5, 10, and 15 mg/kg/day (0.3, 0.65, and 1 times the human induction dose of 2.5 mg/kg based on body surface area) during organogenesis (Gestational Days 6–15). Propofol did not cause adverse effects to the fetus at exposures up to 1 times the human induction dose despite evidence of maternal toxicity (decreased weight gain in all groups). Pregnant rabbits were administered propofol intravenously at 0, 5, 10, and 15 mg/kg/day (0.65, 1.3, 2 times the human induction dose of 2.5 mg/kg based on body surface area comparison) during organogenesis (Gestation Days 6–18).

Propofol treatment decreased total numbers of corpora lutea in all treatment groups but did not cause fetal malformations at any dose despite maternal toxicity (one maternal death from anesthesia-related respiratory depression in the high dose group). Pregnant rats were administered propofol intravenously at 0, 10, and 15 mg/kg/day (0.65 and 1 times the human induction dose of 2.5 mg/kg based on body surface area) from late gestation through lactation (Gestation Day 16 to Lactation Day 22). Decreased pup survival was noted at all doses in the presence of maternal toxicity (deaths from anesthesia- induced respiratory depression).

This study did not evaluate neurobehavioral function including learning and memory in the pups. Pregnant rats were administered propofol intravenously at…

🆘 Overdosage 59 words ▾

10 OVERDOSAGE

10.1Symptoms Overdosage is likely to cause cardiorespiratory depression.

10.2Treatment If overdosage occurs, DIPRIVAN administration should be discontinued immediately. Respiratory depression should be treated by artificial ventilation with oxygen. Cardiovascular depression may require repositioning of the patient by raising the patient's legs, increasing the flow rate of intravenous fluids, and administering pressor agents and/or anticholinergic agents.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY DIPRIVAN is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation. Intravenous injection of a therapeutic dose of propofol induces anesthesia, with minimal excitation, usually within 40 seconds from the start of injection (the time for one arm-brain circulation). As with other rapidly acting intravenous anesthetic agents, the half-time of the blood-brain equilibration is approximately 1 to 3 minutes, accounting for the rate of induction of anesthesia.

12.1Mechanism of Action The mechanism of action, like all general anesthetics, is poorly understood. However, propofol is thought to produce its sedative/anesthetic effects by the positive modulation of the inhibitory function of the neurotransmitter GABA through the ligand-gated GABA A receptors.

12.2Pharmacodynamics Pharmacodynamic properties of propofol are dependent upon the therapeutic blood propofol concentrations. Steady-state propofol blood concentrations are generally proportional to infusion rates. Undesirable side effects, such as cardiorespiratory depression, are likely to occur at higher blood concentrations which result from bolus dosing or rapid increases in infusion rates.

An adequate interval (3 to 5 minutes) must be allowed between dose adjustments in order to assess clinical effects. The hemodynamic effects of DIPRIVAN during induction of anesthesia vary. If spontaneous ventilation is maintained, the major cardiovascular effect is arterial hypotension (sometimes greater than a 30% decrease) with little or no change in heart rate and no appreciable decrease in cardiac output.

If ventilation is assisted or controlled (positive pressure ventilation), there is an increase in the incidence and the degree of depression of cardiac output. Addition of an opioid, used as a premedicant, further decreases cardiac output and respiratory drive. If anesthesia is continued by infusion of DIPRIVAN, the stimulation of endotracheal intubation and surgery may return arterial pressure towards normal.

However, cardiac output may remain depressed. Comparative clinical studies have shown that the hemodynamic effects of DIPRIVAN during induction of anesthesia are generally more pronounced than with other intravenous induction agents. Induction of anesthesia with DIPRIVAN is frequently associated with apnea in both adults and pediatric patients.

In adult patients who received DIPRIVAN (2 mg/kg to 2.5 mg/kg), apnea lasted less than 30 seconds in 7% of patients, 30 seconds to 60 seconds in 24% of patients, and more than 60 seconds in 12% of patients. In pediatric patients from birth through 16 years of age assessable for apnea who received bolus doses of DIPRIVAN (1 mg/kg to 3.6 mg/kg), apnea lasted less than 30 seconds in 12% of patients, 30 seconds to 60 seconds in 10% of patients, and more than 60 seconds in 5% of patients. During maintenance of general anesthesia, DIPRIVAN causes a decrease in spontaneous minute ventilation usually associated with an increase in carbon dioxide tension which may be marked depending upon the rate of administration and concurrent use of other medications (e.g., opioids, sedatives, etc.).

During monitored anesthesia care (MAC) sedation, attention must be given to the cardiorespiratory effects of DIPRIVAN. Hypotension, oxyhemoglobin desaturation, apnea, and airway obstruction can occur, especially following a rapid bolus of DIPRIVAN. During initiation of MAC sedation, slow infusion or slow injection techniques are preferable over rapid bolus administration.

During maintenance of MAC sedation, a variable rate infusion is preferable over intermittent bolus administration in order to minimize undesirable cardiorespiratory effects. In the elderly, debilitated, or ASA-PS III or IV patients, rapid (single or repeated) bolus dose administration should not be used for MAC sedation [see Warnings and Precautions ( 5.12 )] . Clinical and preclinical studies suggest that DIPRI…

🧬 Mechanism of Action 42 words ▾

12.1Mechanism of Action The mechanism of action, like all general anesthetics, is poorly understood. However, propofol is thought to produce its sedative/anesthetic effects by the positive modulation of the inhibitory function of the neurotransmitter GABA through the ligand-gated GABA A receptors.

📦 How Supplied / Storage and Handling 118 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING DIPRIVAN (propofol) injectable emulsion, USP is available as follows: Product Code Each Unit of Sale Strength PRX260929 NDC 63323-269-43 20 mL ready-to-use single-dose vial for single patient use only. NDC 63323-269-94 Packages of ten. 200 mg per 20 mL (10 mg per mL) PRX260950 NDC 63323-269-45 50 mL ready-to-use single-dose vial for single patient use only.

NDC 63323-269-59 Packages of twenty. 500 mg per 50 mL (10 mg per mL) PRX260965 NDC 63323-269-41 100 mL ready-to-use single-dose vial for single patient use only. NDC 63323-269-69 Packages of ten.

1,000 mg per 100 mL vial (10 mg per mL) Store between 4°C to 25°C (40°F to 77°F). Do not freeze. Shake well before use.

📋 Description 143 words ▾

11 DESCRIPTION DIPRIVAN ® (propofol) injectable emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white or almost white homogeneous emulsion for intravenous administration. The structural formula is: Chemical name: 2,6 diisopropylphenol Molecular formula: C 12 H 18 O Molecular weight: 178.27 Propofol is slightly soluble in water. The pKa is 11.

The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of DIPRIVAN ® (Propofol) injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of purified egg phospholipids (12 mg/mL), 0.055 mg of disodium edetate anhydrous (equivalent to 0.055 mg of disodium edetate) (0.05 mg/mL) as microbial inhibitor, and sodium hydroxide to adjust pH, in water for injection. DIPRIVAN is isotonic and has a pH of 7 to 8.5. dipri-struc-01.jpg

💬 Information for Patients 105 words ▾

17 PATIENT COUNSELING INFORMATION

17.1Impaired Mental Alertness Advise patients that performance of activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery or signing legal documents may be impaired for some time after general anesthesia or sedation.

17.2Effect of Anesthetic and Sedation Drugs on Early Brain Development Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains. Discuss with parents and caregivers the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 63323-0265-30 · Fresenius 63323-0272-05 · Fresenius →
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.