Betamethasone Valerate

Product NDC: 54879-004
11-digit product format: 548790004
Labeler code: 54879
Product ID: 54879-004_edabb5da-f600-8bc5-e053-2a95a90a1249
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Betamethasone Valerate
Dosage form: LOTION
Route: CUTANEOUS
Labeler: STI Pharma LLC
Application: ANDA070052
Marketing category: ANDA
Marketing start: 1985-07-31
Marketing end: 0000-00-00
Substance: BETAMETHASONE VALERATE
Active strength: 1 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54879-004-60	2025-04-23	C162847	48780-1	1030e365-2b80-111a-e063-dadaa90a10e2	51faa793-547c-42c0-a01e-8b12e23e2d4b
54879-004-60	2024-01-30	C162847	48780-1	1030e365-2b80-111a-e063-dadaa90a10e2	51faa793-547c-42c0-a01e-8b12e23e2d4b

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54879-004-60	ML - Milliliter	54879-004	c5d444a9-362e-4e1a-8af8-b05af5bb6c61	1	2012-07-24

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9IFA5XM7R2	BETAMETHASONE VALERATE	2152-44-5	BETAMETHASONE VALERATE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54879-004-60	54879000460	1 BOTTLE, PLASTIC in 1 CARTON (54879-004-60) > 60 mL in 1 BOTTLE, PLASTIC	1985-07-31	0000-00-00	No	No	Current