PROPOFOL

Product NDC: 83854-018
Requested package NDC: 83854-018-10
11-digit product format: 838540018
Labeler code: 83854
Product ID: 83854-018_56a34840-59c8-80f2-e063-6294a90a64a7
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]
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog.

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROPOFOL	PROPOFOL	Anthea Pharma Private Limited	f23fe3c5-aa37-4ecc-ad76-f13c1a1dabe2	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 220857 application number: ANDA220857 ndc (package): 83854-018-10 ndc (product): 83854-018 ndc11 (package): 83854001810

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f23fe3c5-aa37-4ecc-ad76-f13c1a1dabe2	Available on FDA.report

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YI7VU623SF	PROPOFOL	2078-54-8	PROPOFOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	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	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PROPOFOL - Anthea Pharma Private Limited	Anthea Pharma Private Limited	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	5