acetazolamide

Product NDC: 16729-331
11-digit product format: 167290331
Labeler code: 16729
Product ID: 16729-331_45ffaa19-26c0-d41f-e063-6394a90ad7c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acetazolamide
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA207659
Marketing category: ANDA
Marketing start: 2021-11-19
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: 2026-12-31
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
A207659-001	ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2018-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207659-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL		2018-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL		2018-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL		2018-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL		2018-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL		2018-10-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL		2018-10-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL		2018-10-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL		2018-10-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207659-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2018-10-18	`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	A207659-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207659-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207659-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207659-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207659-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207659-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207659-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207659-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207659-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207659-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207659-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207659-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207659-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207659-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207659-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207659-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207659-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207659-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207659-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207659-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207659-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207659-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207659-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207659-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207659-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207659-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207659-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207659-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207659-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207659-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207659-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207659-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207659-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: acetazolamide
Listing expiration: 2026-12-31

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
9a368b35-cd51-47ad-83cc-ccc56c4585e8	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
16729-331-01	acetazolamide	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		8
16729-331-17	acetazolamide	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-331-01	EA - Each	16729-331	d55503bb-01fa-4ea4-8761-1461d9ef7c5f	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-331	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ACCORD HEALTHCARE INC.]	7	Current NDC, Legacy NDC, 2 package rows	20250213_9a368b35-cd51-47ad-83cc-ccc56c4585e8.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acetazolamide	ACETAZOLAMIDE	Bryant Ranch Prepack	0d903375-c583-4362-9f8a-f7b74ce01e0b	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207659 application number: ANDA207659
acetazolamide	ACETAZOLAMIDE	Accord Healthcare Inc.	9a368b35-cd51-47ad-83cc-ccc56c4585e8	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207659 application number: ANDA207659 ndc (product): 16729-331

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	0d903375-c583-4362-9f8a-f7b74ce01e0b	103
562524	12 HR acetazolamide 500 MG Extended Release Oral Capsule	SCD	0d903375-c583-4362-9f8a-f7b74ce01e0b	103
562524	acetazolamide 500 MG 12 HR Extended Release Oral Capsule	SY	0d903375-c583-4362-9f8a-f7b74ce01e0b	103
562524	acetaZOLAMIDE 500 MG 12HR Extended Release Oral Capsule	PSN	9a368b35-cd51-47ad-83cc-ccc56c4585e8	8
562524	12 HR acetazolamide 500 MG Extended Release Oral Capsule	SCD	9a368b35-cd51-47ad-83cc-ccc56c4585e8	8
562524	acetazolamide 500 MG 12 HR Extended Release Oral Capsule	SY	9a368b35-cd51-47ad-83cc-ccc56c4585e8	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-331-01	16729033101	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-331-01)	2021-11-19	0000-00-00	No	No	Current
16729-331-17	16729033117	1000 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AcetaZOLAMIDE Extended-Release Capsules	Bryant Ranch Prepack	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	103
AcetaZOLAMIDE Extended-Release Capsules	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2025-12-15	HUMAN PRESCRIPTION DRUG LABEL	8