Acetazolamide

Product NDC: 69367-209
11-digit product format: 693670209
Labeler code: 69367
Product ID: 69367-209_c04410c8-e55f-4f15-a10d-9d94476bde16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetazolamide
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Westminster Pharmaceuticals, LLC
Application: ANDA090779
Marketing category: ANDA
Marketing start: 2023-04-20
Marketing end: 2028-05-01
Substance: ACETAZOLAMIDE
Active strength: 500 mg/1
Pharmacologic classes: Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090779-001	ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090779-001	AB

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL			2011-07-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2011-07-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2011-07-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2011-07-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2011-07-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2011-07-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2011-07-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2011-07-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2011-07-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2011-07-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2011-07-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2011-07-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2011-07-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL			2011-07-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL			2011-07-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL			2011-07-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL			2011-07-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090779-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL			2011-07-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090779-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090779-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090779-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090779-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090779-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090779-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090779-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090779-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090779-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090779-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090779-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090779-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090779-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090779-001	AB	1	`8072bd15b7f6…`
2022-04-08 23:34 UTC	2022-04	A090779-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090779-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090779-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090779-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090779-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090779-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090779-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090779-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090779-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090779-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090779-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090779-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090779-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090779-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090779-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090779-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090779-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090779-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090779-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090779-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090779-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acetazolamide

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAZOLAMIDE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
O3FX965V0I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
562524	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
417b1df2-63bc-473c-9e02-5f93dd45554d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
94b5d997-68ee-d92e-7c04-a34fdb427a66	Product name	9	20240509
d0adda24-c2d3-39f8-a845-ede9cd56b2c4	Product name	6	20210513
91efc97d-7785-4097-b6cf-4201369f41eb	Product name	3	20190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69367-209-01	Acetazolamide	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69367-209-01	EA - Each	69367-209	5f6a3e04-f98f-4ee9-90b4-14c98d63d1f8	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69367-209	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [WESTMINSTER PHARMACEUTICALS, LLC]	2	Current NDC, 1 package rows	20250328_417b1df2-63bc-473c-9e02-5f93dd45554d.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetazolamide	ACETAZOLAMIDE	Westminster Pharmaceuticals, LLC	417b1df2-63bc-473c-9e02-5f93dd45554d	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090779 application number: ANDA090779 ndc (product): 69367-209

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
562524	acetaZOLAMIDE 500 MG 12HR Extended Release Oral Capsule	PSN	417b1df2-63bc-473c-9e02-5f93dd45554d	3
562524	12 HR acetazolamide 500 MG Extended Release Oral Capsule	SCD	417b1df2-63bc-473c-9e02-5f93dd45554d	3
562524	acetazolamide 500 MG 12 HR Extended Release Oral Capsule	SY	417b1df2-63bc-473c-9e02-5f93dd45554d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69367-209-01	69367020901	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69367-209-01)	2023-04-20	2028-05-01	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetazolamide Extended-Release Capsules	Westminster Pharmaceuticals, LLC \| USV Private Limited	2026-02-17	HUMAN PRESCRIPTION DRUG LABEL	3
Acetazolamide Extended-Release Capsules	Proficient Rx LP	2025-05-01	HUMAN PRESCRIPTION DRUG LABEL	1