FDA.reportPublic FDA data

Diprivan

Product NDC
52584-269
11-digit product format
525840269
Labeler code
52584
Product ID
52584-269_bc7ce430-9a37-4654-b256-3a7ef0643e9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diprivan
Dosage form
INJECTION, EMULSION
Route
INTRAVENOUS
Labeler
General Injectables & Vaccines, Inc
Application
NDA019627
Marketing category
NDA
Marketing start
2010-03-01
Marketing end
0000-00-00
Substance
PROPOFOL
Active strength
10 mg/mL
Pharmacologic classes
General Anesthesia [PE],General Anesthetic [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct52584-269IInactivated by FDA2026-07-31
excluded packagepackage52584-26952584-269-50DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019627-001DIPRIVANPROPOFOL10MG/MLINJECTABLE / INJECTION1989-10-02
N019627-002DIPRIVANPROPOFOL10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019627-002AB

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 22:54:322026-06N019627-001DIPRIVAN10MG/MLINJECTABLE / INJECTION1989-10-02a50c72e98297…
2026-08-01 22:54:322026-06N019627-002DIPRIVAN10MG/MLINJECTABLE / INJECTIONABRLD, RS1996-06-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N019627-002AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DiprivanPROPOFOLFresenius Kabi USA, LLCe3105799-a4b6-f3f4-e6e2-b2b29bbdb5382025-09-11Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627
DiprivanPROPOFOLFresenius Kabi USA, LLCfee3bd4a-ade3-41fa-839a-48e9af69bcf42025-09-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627
DiprivanPROPOFOLFresenius Kabi USA, LLCd1ae9e26-ffd6-43df-bbd6-869cdede6afe2025-04-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627
DiprivanPROPOFOLFresenius Kabi USA, LLCee0c3437-614d-4631-a061-257f5f60c70b2025-02-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627
DiprivanPROPOFOLFresenius Kabi USA, LLC5cec3b97-5183-4a9d-accd-21e76c99d3dd2024-04-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b5dd1a36-1efc-430d-94c2-9f49a850da5fProduct name620250317

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52584-269-502020-01-31C16284748780-19d75b9d0-43ff-f424-e053-dadaa90a57ceDiprivan 1% Injection Emulsion (propofol) 10 mg/mL Injectable Emulsion 50 mL Vial

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52584-269-50Diprivan50 mL in 1 VIALINJECTION, EMULSION503
52584-269-50Diprivan1 in 1 BAGINJECTION, EMULSION13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PropofolACTIVE INGREDIENTYI7VU623SFDIPRIVAN INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]2
PropofolACTIVE MOIETYYI7VU623SFDIPRIVAN INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52584-269DIPRIVAN INJECTION, EMULSION [GENERAL INJECTABLES & VACCINES, INC]3Legacy NDC, 2 package rows20170119_7603f1ba-cfbd-4ec5-881a-13f4832c9893.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1808222propofol 500 MG in 50 ML InjectionPSN7603f1ba-cfbd-4ec5-881a-13f4832c98933
180822250 ML propofol 10 MG/ML InjectionSCD7603f1ba-cfbd-4ec5-881a-13f4832c98933
1808222propofol 500 MG per 50 ML InjectionSY7603f1ba-cfbd-4ec5-881a-13f4832c98933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52584-269-505258402695050 mL in 1 VIAL50 mlHistorical