Anesthesia S/I-40

Product NDC
49836-025
11-digit product format
498360025
Labeler code
49836
Product ID
49836-025_79b5d917-ebef-4771-a8b0-eb78c05ef8b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Propofol, Isopropyl Alcohol
Dosage form
KIT
Labeler
RX PHARMA-PACK, INC.
Application
NDA019627
Marketing category
NDA
Marketing start
2017-08-24
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct49836-025DDiscontinued by firm2026-07-31
excluded packagepackage49836-02549836-025-09DDiscontinued 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49836-025-09EA - Each49836-0258510dab5-8c82-4ebc-a159-46d892ea8dbd12017-09-11