FDA.reportPublic FDA data

Propofol

Product NDC
0591-2136
Requested package NDC
0591-2136-68
11-digit product format
005912136
Labeler code
0591
Product ID
0591-2136_56a483ca-e68c-4847-863d-eb186645673f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propofol
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
Actavis Pharma, Inc.
Application
ANDA205307
Marketing category
ANDA
Marketing start
2016-01-07
Marketing end
2023-09-30
Substance
PROPOFOL
Active strength
10 mg/mL
Pharmacologic classes
General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0591-21360591-2136-68DDiscontinued 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
A205307-001PROPOFOLPROPOFOL10MG/MLINJECTABLE / INJECTION2015-12-22

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 22:54:322026-06A205307-001PROPOFOL10MG/MLINJECTABLE / INJECTION2015-12-22a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2136-51ML - Milliliter0591-21360b14f2f2-28a4-4fb5-a669-08abd4efc03a12016-02-04
0591-2136-55ML - Milliliter0591-2136c7340b05-171e-42b9-9aaa-f4423b6cba5b12016-02-04
0591-2136-57ML - Milliliter0591-213620f74f85-7313-40e5-a1bd-99d35d50d3cd12016-02-04
0591-2136-68ML - Milliliter0591-213647d8a6dd-b9a7-457a-a1e8-e8e835d9157a12016-02-04
0591-2136-80ML - Milliliter0591-2136ecc8f542-06b4-4ab8-8638-70de2da9f8bd12016-02-04
0591-2136-95ML - Milliliter0591-21360d8814c1-098b-4f9e-8b00-4e25f3db5dc812016-02-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2136-680059121366810 VIAL in 1 CARTON (0591-2136-68) > 100 mL in 1 VIAL (0591-2136-57) 10 vial2016-01-072023-05-31NoNoCurrent