Home NDC 36000-058 Propofol
Product NDC 36000-058
11-digit product format 360000058
Labeler code 36000
Product ID 36000-058_7327d19b-7bd0-45be-a611-e814a3a5ee88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Propofol
Dosage form INJECTION, EMULSION
Route INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA203421
Marketing category ANDA
Marketing start 2026-11-03
Substance PROPOFOL
Active strength 10 mg/mL
Pharmacologic classes General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 A203421-001 PROPOFOL PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2026-11-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203421-001 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 2026-11-14 07:37:17 2026-10 A203421-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2026-11-03 d4dbc9d85df4…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-11-14 07:37:17 2026-10 A203421-001 AB 1 d4dbc9d85df4…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Propofol
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1808224 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 36000-058-10 36000005810 10 VIAL, SINGLE-DOSE in 1 CARTON (36000-058-10) / 20 mL in 1 VIAL, SINGLE-DOSE (36000-058-01) 2026-11-03 No No Current