FDA.reportPublic FDA data

Propofol

Product NDC
72572-583
11-digit product format
725720583
Labeler code
72572
Product ID
72572-583_9db78e67-e664-4151-a8bf-46d2225bfce5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propofol
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA074848
Marketing category
ANDA
Marketing start
2020-09-03
Marketing end
0000-00-00
Substance
PROPOFOL
Active strength
10 mg/mL
Pharmacologic classes
General Anesthesia [PE],General Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72572-583DDiscontinued by firm2026-07-31
excluded packagepackage72572-58372572-583-10DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074848-001PROPOFOLPROPOFOL10MG/MLINJECTABLE / INJECTIONAB2005-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A074848-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A074848-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2005-04-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A074848-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROPOFOLPROPOFOLHikma Pharmaceuticals USA Inc.fdb77e13-f5a7-4c4a-9f8e-338b702239c82022-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074848
application number: ANDA074848

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-583-01ML - Milliliter72572-583ef4272ca-a5d5-4c1a-a422-ebcf080a645112021-03-02
72572-583-10ML - Milliliter72572-58386b22545-375f-40d8-9084-df50ed5afc2f12021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72572-583-107257205831010 VIAL, SINGLE-USE in 1 CARTON (72572-583-10) > 20 mL in 1 VIAL, SINGLE-USE (72572-583-01) 2020-09-030000-00-00NoNoCurrent