acetazolamide

Product NDC: 60687-578
11-digit product format: 606870578
Labeler code: 60687
Product ID: 60687-578_365ff016-96db-785d-e063-6394a90aaada
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acetazolamide
Dosage form: CAPSULE
Route: ORAL
Labeler: American Health Packaging
Application: ANDA205301
Marketing category: ANDA
Marketing start: 2020-10-27
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
A205301-001	ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205301-001	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	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-01-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-01-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-01-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-01-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-01-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-01-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-01-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-01-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-01-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-01-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2019-01-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205301-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2019-01-16	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205301-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205301-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205301-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205301-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205301-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205301-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205301-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205301-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205301-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205301-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205301-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205301-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205301-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205301-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205301-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205301-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205301-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205301-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205301-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205301-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205301-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205301-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205301-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205301-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205301-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205301-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205301-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205301-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205301-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205301-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205301-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205301-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205301-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205301-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205301-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205301-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205301-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205301-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205301-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205301-001	AB	1	`cb3db0bc1861…`

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
4e8797d9-2e78-49e0-af25-ac5d1f792499	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
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
60687-578-11	acetazolamide	1 in 1 BLISTER PACK	CAPSULE	1		5
60687-578-21	acetazolamide	30 in 1 BOX, UNIT-DOSE	CAPSULE	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60687-578	ACETAZOLAMIDE CAPSULE [AMERICAN HEALTH PACKAGING]	4	Current NDC, Legacy NDC, 2 package rows	20241024_4e8797d9-2e78-49e0-af25-ac5d1f792499.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
acetazolamide	ACETAZOLAMIDE	American Health Packaging	4e8797d9-2e78-49e0-af25-ac5d1f792499	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205301 application number: ANDA205301 ndc (product): 60687-578
acetazolamide	ACETAZOLAMIDE	Zydus Pharmaceuticals (USA) Inc.	bf514e99-4958-44a0-a87a-02a950f87e60	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205301 application number: ANDA205301
acetazolamide	ACETAZOLAMIDE	Zydus Lifesciences Limited	2c1d9078-c15f-4dce-bc26-edfa5400fa9b	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205301 application number: ANDA205301

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	4e8797d9-2e78-49e0-af25-ac5d1f792499	5
562524	12 HR acetazolamide 500 MG Extended Release Oral Capsule	SCD	4e8797d9-2e78-49e0-af25-ac5d1f792499	5
562524	acetazolamide 500 MG 12 HR Extended Release Oral Capsule	SY	4e8797d9-2e78-49e0-af25-ac5d1f792499	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60687-578-11	60687057811	1 in 1 BLISTER PACK						Historical
60687-578-21	60687057821	30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-578-21) / 1 CAPSULE in 1 BLISTER PACK (60687-578-11)	30 blister pack	2020-10-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetazolamide Extended-Release Capsules, USP 8457821/1124 Rx only	American Health Packaging	2025-05-30	HUMAN PRESCRIPTION DRUG LABEL	5