ACETAZOLAMIDE EXTENDED-RELEASE

Product NDC: 42571-243
11-digit product format: 425710243
Labeler code: 42571
Product ID: 42571-243_456f5ce4-6ad1-f0a1-e063-6294a90a0fac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetazolamide extended-release
Dosage form: CAPSULE
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA207401
Marketing category: ANDA
Marketing start: 2020-12-01
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
A207401-001	ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2020-10-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207401-001	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.

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	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207401-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-10-01	`a50c72e98297…`

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	A207401-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207401-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207401-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207401-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207401-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207401-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207401-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207401-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207401-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207401-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207401-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207401-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207401-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207401-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207401-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207401-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207401-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207401-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207401-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207401-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207401-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207401-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207401-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207401-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207401-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207401-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207401-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207401-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207401-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207401-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207401-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207401-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207401-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207401-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207401-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207401-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207401-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: ACETAZOLAMIDE EXTENDED-RELEASE
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
78f78919-a6ba-4072-bc45-2ab3637ed894	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
42571-243-01	ACETAZOLAMIDE EXTENDED-RELEASE	100 in 1 BOTTLE	CAPSULE	100		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42571-243-01	EA - Each	42571-243	223f7fcd-09ea-41da-9aa0-f1c54bc62d39	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-243	ACETAZOLAMIDE EXTENDED-RELEASE (ACETAZOLAMIDE EXTENDED-RELEASE) CAPSULE [MICRO LABS LIMITED]	6	Current NDC, Legacy NDC, 1 package rows	20250112_78f78919-a6ba-4072-bc45-2ab3637ed894.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 EXTENDED-RELEASE	ACETAZOLAMIDE EXTENDED-RELEASE	Micro Labs Limited	78f78919-a6ba-4072-bc45-2ab3637ed894	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207401 application number: ANDA207401 ndc (product): 42571-243
ACETAZOLAMIDE EXTENDED-RELEASE	ACETAZOLAMIDE EXTENDED-RELEASE	AvPAK	e43f991d-15b9-1e66-e053-2a95a90a9449	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207401 application number: ANDA207401

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	78f78919-a6ba-4072-bc45-2ab3637ed894	7
562524	12 HR acetazolamide 500 MG Extended Release Oral Capsule	SCD	78f78919-a6ba-4072-bc45-2ab3637ed894	7
562524	acetazolamide 500 MG 12 HR Extended Release Oral Capsule	SY	78f78919-a6ba-4072-bc45-2ab3637ed894	7
562524	acetaZOLAMIDE 500 MG 12HR Extended Release Oral Capsule	PSN	e43f991d-15b9-1e66-e053-2a95a90a9449	2
562524	12 HR acetazolamide 500 MG Extended Release Oral Capsule	SCD	e43f991d-15b9-1e66-e053-2a95a90a9449	2
562524	acetazolamide 500 MG 12 HR Extended Release Oral Capsule	SY	e43f991d-15b9-1e66-e053-2a95a90a9449	2
562524	acetaZOLAMIDE 500 MG 12HR Extended Release Oral Capsule	PSN	8e396b27-b44a-4aa9-805b-086395444b5f	1
562524	12 HR acetazolamide 500 MG Extended Release Oral Capsule	SCD	8e396b27-b44a-4aa9-805b-086395444b5f	1
562524	acetazolamide 500 MG 12 HR Extended Release Oral Capsule	SY	8e396b27-b44a-4aa9-805b-086395444b5f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-243-01	42571024301	100 CAPSULE in 1 BOTTLE (42571-243-01)	100 capsule	2020-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetazolamide Extended-Release Capsules, USP Rx only	Micro Labs Limited	2025-12-08	HUMAN PRESCRIPTION DRUG LABEL	7
Acetazolamide Extended Release	AvPAK	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	2
Acetazolamide Extended-Release Capsules Issued JUNE 2014 Rx only	A-S Medication Solutions	2021-09-03	HUMAN PRESCRIPTION DRUG LABEL	1