FDA.reportPublic FDA data

Application 019627

Type
NDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPRIVANPROPOFOLINJECTABLE;INJECTION10MG/MLNoNo
002DIPRIVANPROPOFOLINJECTABLE;INJECTION10MG/MLYesYes

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
ndc (product): 63323-269
DiprivanPROPOFOLFresenius Kabi USA, LLCfee3bd4a-ade3-41fa-839a-48e9af69bcf42025-09-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627
ndc (product): 63323-269
DiprivanPROPOFOLFresenius Kabi USA, LLCd1ae9e26-ffd6-43df-bbd6-869cdede6afe2025-04-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627
ndc (product): 63323-269
DiprivanPROPOFOLFresenius Kabi USA, LLCee0c3437-614d-4631-a061-257f5f60c70b2025-02-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627
ndc (product): 63323-269
DiprivanPROPOFOLFresenius Kabi USA, LLC5cec3b97-5183-4a9d-accd-21e76c99d3dd2024-04-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 019627
application number: NDA019627
ndc (product): 65219-800

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
49836-024Anesthesia S/I-60Propofol, Sterile Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-024Anesthesia S/I-60Propofol, Sterile Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-024Anesthesia S/I-60Propofol, Sterile Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-025Anesthesia S/I-40Propofol, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-025Anesthesia S/I-40Propofol, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-025Anesthesia S/I-40Propofol, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
52584-269DiprivanDiprivanGeneral Injectables & Vaccines, IncNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
63323-269DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
65219-800DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
65219-800DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent
65219-800DiprivanPROPOFOLFresenius Kabi USA, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85080SUPPL 2026-02-19
85079SUPPL 2026-02-19
71993SUPPL2022-09-01
71986SUPPL2022-09-01
68284SUPPL2021-08-04
67461SUPPL2021-05-12
48220SUPPL2017-05-02
48192SUPPL2017-05-02
33816SUPPL2014-06-10
11571SUPPL2014-01-28
40941SUPPL2013-09-24
17492SUPPL2013-09-17
40940SUPPL2009-01-12
20269SUPPL2009-01-12
11570SUPPL2008-04-23
17491SUPPL2008-04-16
20268SUPPL2007-07-09
20267SUPPL2007-07-09
23549ORIG2007-06-18
11569SUPPL2007-02-21
17490SUPPL2007-02-12
11568SUPPL2001-02-23
1425SUPPL2001-02-23