ACETAZOLAMIDE

Product NDC: 68382-261
11-digit product format: 683820261
Labeler code: 68382
Product ID: 68382-261_a716c034-37bf-4646-a49f-5c827e7cc6a7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: acetazolamide
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA040904
Marketing category: ANDA
Marketing start: 2008-12-15
Marketing end: 2020-11-30
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: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68382-261		D	Discontinued by firm	2026-08-10
excluded package	package	68382-261	68382-261-01	D	Discontinued by firm	2026-08-10
excluded package	package	68382-261	68382-261-10	D	Discontinued by firm	2026-08-10

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 · 39 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-261-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68382-261-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-261-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68382-261-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-261-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68382-261-10	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-261-01	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68382-261-10	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-261-01	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68382-261-10	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-261-01	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68382-261-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-261-01	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68382-261-10	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-261-01	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68382-261-10	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-261-01	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68382-261-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-261-01	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68382-261-10	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68382-261-01	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68382-261-10	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68382-261-01	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68382-261-10	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68382-261-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68382-261-10	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68382-261-01	2020-02-07	Acetazolamide Extended-Release Capsules Rx only
68382-261-10	2020-02-07	Acetazolamide Extended-Release Capsules Rx only
68382-261-01	2020-01-31	Acetazolamide Extended-Release Capsules Rx only
68382-261-10	2020-01-31	Acetazolamide Extended-Release Capsules Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-261-01	EA - Each	68382-261	7fc26c75-98eb-4f44-a2a3-7c54cfef2ae4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAZOLAMIDE	ACTIVE INGREDIENT	O3FX965V0I	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	4
ACETAZOLAMIDE	ACTIVE MOIETY	O3FX965V0I	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	4
AMMONIO METHACRYLATE COPOLYMER TYPE A	INACTIVE INGREDIENT	8GQS4E66YY	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	4
AMMONIO METHACRYLATE COPOLYMER TYPE B	INACTIVE INGREDIENT	161H3B14U2	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	4
ACETAZOLAMIDE	ACTIVE INGREDIENT	O3FX965V0I	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
ACETAZOLAMIDE	ACTIVE MOIETY	O3FX965V0I	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]	3

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
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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetazolamide Extended-Release Capsules Rx only	Zydus Pharmaceuticals USA Inc. \| Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	2020-06-05	HUMAN PRESCRIPTION DRUG LABEL	6
Acetazolamide Extended-Release Capsules	American Health Packaging	2019-02-26	HUMAN PRESCRIPTION DRUG LABEL	5