Home NDC 83854-018 PROPOFOL
Product NDC 83854-018
11-digit product format 838540018
Labeler code 83854
Product ID 83854-018_5c98e309-8b86-4513-e063-6294a90aa881
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name PROPOFOL
Dosage form INJECTION, EMULSION
Route INTRAVENOUS
Labeler Anthea Pharma Private Limited
Application ANDA220857
Marketing category ANDA
Marketing start 2026-07-14
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 43 .
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 A220857-001 PROPOFOL PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2026-07-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220857-001 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 2026-09-14 22:38:34 2026-08 A220857-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2026-07-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220857-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2026-07-14 caaa826d4ba7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A220857-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220857-001 AB 1 caaa826d4ba7…
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83854-018-10 83854001810 10 VIAL in 1 CARTON (83854-018-10) / 20 mL in 1 VIAL (83854-018-01) 10 vial 2026-07-14 No No Current 83854-018-14 83854001814 20 VIAL in 1 CARTON (83854-018-14) / 20 mL in 1 VIAL (83854-018-01) 20 vial 2026-09-10 No No Current 83854-018-15 83854001815 25 VIAL in 1 CARTON (83854-018-15) / 20 mL in 1 VIAL (83854-018-01) 25 vial 2026-09-10 No No Current 83854-018-16 83854001816 1 VIAL in 1 CARTON (83854-018-16) / 20 mL in 1 VIAL (83854-018-01) 1 vial 2026-09-10 No No Current