Acetazolamide

Product NDC: 70518-4646
11-digit product format: 705184646
Labeler code: 70518
Product ID: 70518-4646_508b15b8-2f21-c075-e063-6394a90af64d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetazolamide
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA040904
Marketing category: ANDA
Marketing start: 2026-04-28
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: 2027-12-31
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
A040904-001	ACETAZOLAMIDE	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2008-12-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040904-001	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	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040904-001	ACETAZOLAMIDE	500MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2008-12-10	`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	A040904-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040904-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040904-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040904-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040904-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040904-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040904-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040904-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040904-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040904-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040904-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040904-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040904-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040904-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040904-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040904-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040904-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040904-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040904-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040904-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040904-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040904-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040904-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040904-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040904-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040904-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040904-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040904-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040904-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040904-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040904-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040904-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040904-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040904-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040904-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040904-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040904-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040904-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040904-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040904-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Acetazolamide
Listing expiration: 2027-12-31

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
fb2cf8fe-da81-445e-a18b-9aa9ced1d34a	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
70518-4646-0	Acetazolamide	50 in 1 BOX	CAPSULE, EXTENDED RELEASE	50		1
70518-4646-1	Acetazolamide	1 in 1 POUCH	CAPSULE, EXTENDED RELEASE	1		1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetazolamide	ACETAZOLAMIDE	A-S Medication Solutions	c5acf531-ba55-47b7-88db-e5da0206ebf1	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040904 application number: ANDA040904
Acetazolamide	ACETAZOLAMIDE	REMEDYREPACK INC.	fb2cf8fe-da81-445e-a18b-9aa9ced1d34a	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040904 application number: ANDA040904 ndc (product): 70518-4646
Acetazolamide	ACETAZOLAMIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	33d912ea-9e1c-49eb-bd93-f0b1b2da67b6	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040904 application number: ANDA040904
Acetazolamide	ACETAZOLAMIDE	Chartwell RX, LLC	e8e48a25-5f6c-4b5a-a5f2-ee87aabea33b	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040904 application number: ANDA040904

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	fb2cf8fe-da81-445e-a18b-9aa9ced1d34a	1
562524	12 HR acetazolamide 500 MG Extended Release Oral Capsule	SCD	fb2cf8fe-da81-445e-a18b-9aa9ced1d34a	1
562524	acetazolamide 500 MG 12 HR Extended Release Oral Capsule	SY	fb2cf8fe-da81-445e-a18b-9aa9ced1d34a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4646-0	70518464600	50 POUCH in 1 BOX (70518-4646-0) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4646-1)	50 pouch	2026-04-28	No	No	Current
70518-4646-1	70518464601	1 in 1 POUCH					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetazolamide Extended-Release Capsule, USP Rx Only	REMEDYREPACK INC.	2026-04-28	HUMAN PRESCRIPTION DRUG LABEL	1