Home NDC 83854-018-16 PROPOFOL
Product NDC 83854-018
Requested package NDC 83854-018-16
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 44 .
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 2026-10-15 13:18:30 2026-09 A220857-001 PROPOFOL 10MG/ML INJECTABLE / INJECTION AB 2026-07-14 c2088c7a36db…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# 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 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