Acetazolamide

Product NDC: 50090-3132
Requested package NDC: 50090-3132-0
11-digit product format: 500903132
Labeler code: 50090
Product ID: 50090-3132_4db9b259-b15f-4d79-b892-483d4f182297
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acetazolamide
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA090779
Marketing category: ANDA
Marketing start: 2012-09-24
Marketing end: 0000-00-00
Substance: ACETAZOLAMIDE
Active strength: 500 mg/1
Pharmacologic classes: Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-3132	50090-3132-0	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3132-0	2023-01-30	C162847	48780-1	f386c64a-49f5-0266-e053-dadaa90a7c1a	Acetazolamide Extended-Release Capsules These highlights do not include all the information needed to use Acetazolamide safely and effectively. See full prescribing information for Acetazolamide Acetazolamide (Acetazolamide) CAPSULE, EXTENDED RELEASE for ORAL use. Initial U.S. Approval:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3132-0	Acetazolamide	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3132-0	EA - Each	50090-3132	2981d8ff-f2a1-4bf1-b8df-0794a76c455b	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3132	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]	5	Legacy NDC, 1 package rows	20210417_98ee6c4e-cfe4-4fd0-b04f-2a5fd9c490c9.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

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	98ee6c4e-cfe4-4fd0-b04f-2a5fd9c490c9	5
562524	12 HR acetazolamide 500 MG Extended Release Oral Capsule	SCD	98ee6c4e-cfe4-4fd0-b04f-2a5fd9c490c9	5
562524	acetazolamide 500 MG 12 HR Extended Release Oral Capsule	SY	98ee6c4e-cfe4-4fd0-b04f-2a5fd9c490c9	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3132-0	50090313200	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3132-0)	2017-09-06	0000-00-00	No	No	Current