FDA.reportPublic FDA data

Propofol

Product NDC
50090-4569
Requested package NDC
50090-4569-1
11-digit product format
500904569
Labeler code
50090
Product ID
50090-4569_a81abb0a-495a-4b53-9d04-8b8d1f973a29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propofol
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
A-S Medication Solutions
Application
ANDA205307
Marketing category
ANDA
Marketing start
2016-01-07
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-456950090-4569-1DDiscontinued 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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4569-12025-09-16C16284748780-1f386c649-bd0c-0266-e053-dadaa90a7c1aPropofol Injectable Emulsion, USP Rx only
50090-4569-12023-01-30C16284748780-1f386c649-bd0c-0266-e053-dadaa90a7c1aPropofol Injectable Emulsion, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4569-1ML - Milliliter50090-456916b84847-e332-474d-98ba-cb6b3441c3c712022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4569PROPOFOL INJECTION, EMULSION [A-S MEDICATION SOLUTIONS]4Legacy NDC20210417_475de1f2-9b88-455a-ba3c-48e96083c056.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4569-15009045690150 mL in 1 VIAL (50090-4569-1) 50 ml2019-09-270000-00-00NoNoCurrent