Acetazolamide

Product NDC: 63629-1195
11-digit product format: 636291195
Labeler code: 63629
Product ID: 63629-1195_800d56b2-c458-4fb5-a040-14d5b4bf9fbf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetazolamide
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA214282
Marketing category: ANDA
Marketing start: 2020-11-13
Substance: ACETAZOLAMIDE
Active strength: 250 mg/1
Pharmacologic classes: Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 63629-1195_800d56b2-c458-4fb5-a040-14d5b4bf9fbf
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Acetazolamide
Generic name: Acetazolamide
Dosage form: TABLET
Route: ORAL
Marketing start: 2020-11-13
Marketing category: ANDA
Application number: ANDA214282
Pharmacologic classes: Carbonic Anhydrase Inhibitor [EPC]; Carbonic Anhydrase Inhibitors [MoA]; Sulfonamides [CS]
Listing expiration: 2026-12-31

Ingredient	Strength
ACETAZOLAMIDE	250 mg/1

UNII	Preferred term	Registry number	Matched term
O3FX965V0I	ACETAZOLAMIDE	59-66-5	ACETAZOLAMIDE

Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-1195-1	63629119501	100 TABLET in 1 BOTTLE (63629-1195-1)	100 tablet	2020-11-13	0000-00-00	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Acetazolamide Tablets USP	Bryant Ranch Prepack	2024-10-29	HUMAN PRESCRIPTION DRUG LABEL	107