Acetazolamide

Product NDC: 50268-054
11-digit product format: 502680054
Labeler code: 50268
Product ID: 50268-054_47e22404-7bca-908d-e063-6294a90a70c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetazolamide
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA209734
Marketing category: ANDA
Marketing start: 2020-07-07
Substance: ACETAZOLAMIDE
Active strength: 250 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209734-001	ACETAZOLAMIDE	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB		2017-11-20
A209734-002	ACETAZOLAMIDE	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB		2017-11-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A209734-001	AB
A209734-002	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 3 · 82 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	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209734-001	ACETAZOLAMIDE	125MG	TABLET / ORAL	AB	2017-11-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209734-002	ACETAZOLAMIDE	250MG	TABLET / ORAL	AB	2017-11-20	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A209734-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209734-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209734-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209734-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209734-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209734-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209734-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209734-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209734-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209734-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209734-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209734-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209734-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209734-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209734-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209734-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209734-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209734-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209734-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209734-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209734-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209734-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209734-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209734-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209734-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209734-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209734-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209734-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209734-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209734-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209734-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209734-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209734-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209734-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209734-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209734-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209734-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209734-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209734-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209734-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAZOLAMIDE	250 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
197304	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
a9dca448-5511-413e-e053-2a95a90a8c66	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
50268-054-11	Acetazolamide	1 in 1 BLISTER PACK	TABLET	1		4
50268-054-15	Acetazolamide	50 in 1 BOX	TABLET	50		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-054-11	EA - Each	50268-054	bf8f41a5-c89f-4e22-ac85-b98962c1a18d	1	2020-08-06
50268-054-15	EA - Each	50268-054	62353d97-515b-4af7-a52e-23a32047f62d	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-054	ACETAZOLAMIDE TABLET [AVPAK]	3	Current NDC, Legacy NDC, 2 package rows	20240110_a9dca448-5511-413e-e053-2a95a90a8c66.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetazolamide	ACETAZOLAMIDE	PD-Rx Pharmaceuticals, Inc.	268db224-d5db-457c-86bc-972c9fe07917	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209734 application number: ANDA209734
Acetazolamide	ACETAZOLAMIDE	Strides Pharma Science Limited	4813b9dd-5f58-44bb-ad64-cdb331828080	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209734 application number: ANDA209734
Acetazolamide	ACETAZOLAMIDE	AvPAK	a9dca448-5511-413e-e053-2a95a90a8c66	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209734 application number: ANDA209734 ndc (product): 50268-054
Acetazolamide	ACETAZOLAMIDE	NuCare Pharmaceuticlas, Inc.	278878bc-da9c-09d4-e063-6394a90abaf7	2024-11-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209734 application number: ANDA209734
Acetazolamide	ACETAZOLAMIDE	A-S Medication Solutions	e9152bc5-5817-4a6a-9d2a-0dd77074f501	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209734 application number: ANDA209734
Acetazolamide	ACETAZOLAMIDE	Proficient Rx LP	3cdde6aa-c89d-4ea4-aade-6c8b5c3ffdcc	2019-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209734 application number: ANDA209734

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
197304	acetaZOLAMIDE 250 MG Oral Tablet	PSN	a9dca448-5511-413e-e053-2a95a90a8c66	4
197304	acetazolamide 250 MG Oral Tablet	SCD	a9dca448-5511-413e-e053-2a95a90a8c66	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-054-11	50268005411	1 in 1 BLISTER PACK						Historical
50268-054-15	50268005415	50 BLISTER PACK in 1 BOX (50268-054-15) / 1 TABLET in 1 BLISTER PACK (50268-054-11)	50 blister pack	2020-07-07	0000-00-00	No	No	Current