Home NDC 0641-6195 PROPOFOL
Product NDC 0641-6195
11-digit product format 006416195
Labeler code 0641
Product ID 0641-6195_113ac304-ef02-4891-ac8b-8788f4ea041c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROPOFOL
Dosage form INJECTION, EMULSION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA074848
Marketing category ANDA
Marketing start 2020-05-01
Substance PROPOFOL
Active strength 10 mg/mL
Pharmacologic classes General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074848-001 PROPOFOL PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074848-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A074848-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2005-04-19 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A074848-001 AB 1 a50c72e98297…
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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base PROPOFOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROPOFOL 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YI7VU623SF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1808217 Internal RxNorm lookup 1808222 Internal RxNorm lookup 1808224 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0641-6195-01 PROPOFOL 50 mL in 1 VIAL, SINGLE-USE INJECTION, EMULSION 50 3 0641-6195-20 PROPOFOL 20 in 1 CARTON INJECTION, EMULSION 20 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-6195 PROPOFOL INJECTION, EMULSION [HIKMA PHARMACEUTICALS USA INC.] 3 Current NDC, Legacy NDC, 2 package rows 20230124_fdb77e13-f5a7-4c4a-9f8e-338b702239c8.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0641-6195-01 00641619501 50 mL in 1 VIAL, SINGLE-USE 50 ml Historical 0641-6195-20 00641619520 20 VIAL, SINGLE-USE in 1 CARTON (0641-6195-20) / 50 mL in 1 VIAL, SINGLE-USE (0641-6195-01) 2020-05-01 0000-00-00 No No Current