Nabumetone

Product NDC: 63629-8508
11-digit product format: 636298508
Labeler code: 63629
Product ID: 63629-8508_23de2d32-a24a-42f7-93c1-8906323878d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nabumetone
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078420
Marketing category: ANDA
Marketing start: 2019-06-26
Substance: NABUMETONE
Active strength: 500 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 63629-8508_23de2d32-a24a-42f7-93c1-8906323878d3
SPL ID: 23de2d32-a24a-42f7-93c1-8906323878d3
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Nabumetone
Generic name: Nabumetone
Dosage form: TABLET
Route: ORAL
Marketing start: 2019-06-26
Marketing category: ANDA
Application number: ANDA078420
Pharmacologic classes: Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]
Listing expiration: 2026-12-31

Ingredient	Strength
NABUMETONE	500 mg/1

Package NDC	Description	Marketing start	Sample
63629-8508-1	100 TABLET in 1 BOTTLE (63629-8508-1)	2019-06-26	No

UNII	Preferred term	Registry number	Matched term
LW0TIW155Z	NABUMETONE	42924-53-8	NABUMETONE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63629-8508-1	63629850801	100 TABLET in 1 BOTTLE (63629-8508-1)	100 tablet	2019-06-26	No	No	Historical

Title	Manufacturer	Effective date	Type	Version
NABUMETONE TABLETS USP Rx Only	Bryant Ranch Prepack	2025-03-26	HUMAN PRESCRIPTION DRUG LABEL	104