FDA.reportPublic FDA data

PROPOFOL

Product NDC
83854-018
Requested package NDC
83854-018-10
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220857-001PROPOFOLPROPOFOL10MG/MLINJECTABLE / INJECTIONAB2026-07-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A220857-001AB

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
2026-09-14 22:38:342026-08A220857-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2026-07-1484e616aacf4f…
2026-08-18 06:07:402026-07A220857-001PROPOFOL10MG/MLINJECTABLE / INJECTIONAB2026-07-14caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220857-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A220857-001AB1caaa826d4ba7…

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
IngredientStrength
PROPOFOL10 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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROPOFOLPROPOFOLAnthea Pharma Private Limitedf23fe3c5-aa37-4ecc-ad76-f13c1a1dabe22026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220857
application number: ANDA220857
ndc (package): 83854-018-10
ndc (product): 83854-018
ndc11 (package): 83854001810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83854-018-108385400181010 VIAL in 1 CARTON (83854-018-10) / 20 mL in 1 VIAL (83854-018-01) 10 vial2026-07-14NoNoCurrent