Methazolamide

Product NDC: 68682-023
11-digit product format: 686820023
Labeler code: 68682
Product ID: 68682-023_0962cf33-b872-4006-82f8-8610567a07d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methazolamide
Dosage form: TABLET
Route: ORAL
Labeler: Oceanside Pharmaceuticals
Application: ANDA207438
Marketing category: ANDA
Marketing start: 2020-10-02
Marketing end: 0000-00-00
Substance: METHAZOLAMIDE
Active strength: 50 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68682-023		D	Discontinued by firm	2026-08-17
excluded package	package	68682-023	68682-023-01	D	Discontinued by firm	2026-08-17
excluded package	package	68682-023	68682-023-10	D	Discontinued by firm	2026-08-17
excluded package	package	68682-023	68682-023-50	D	Discontinued by firm	2026-08-17
excluded package	package	68682-023	68682-023-90	D	Discontinued by firm	2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207438-001	METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET / ORAL	AB		2018-10-05
A207438-002	METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET / ORAL	AB		2018-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207438-001	AB
A207438-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL		2018-10-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL		2018-10-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207438-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	2018-10-05	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207438-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	2018-10-05	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A207438-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207438-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207438-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207438-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207438-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207438-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207438-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207438-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207438-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207438-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207438-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207438-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207438-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207438-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207438-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207438-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207438-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207438-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207438-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207438-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207438-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207438-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207438-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207438-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207438-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207438-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207438-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207438-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207438-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207438-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207438-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207438-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207438-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207438-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207438-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207438-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207438-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207438-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207438-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207438-002	AB	1	`782e0a99824c…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-023	METHAZOLAMIDE TABLET [OCEANSIDE PHARMACEUTICALS]	1	Legacy NDC	20201002_0962cf33-b872-4006-82f8-8610567a07d6.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
Methazolamide	METHAZOLAMIDE	Bausch & Lomb Incorporated	0c0ba5c7-c53e-4e29-a7ff-48fddc5a9258	2025-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207438 application number: ANDA207438
METHAZOLAMIDE	METHAZOLAMIDE	Micro Labs Limited	91a493f5-f8c3-4b64-a15e-b550d8631668	2020-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207438 application number: ANDA207438

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W733B0S9SD	METHAZOLAMIDE	554-57-4	METHAZOLAMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-023-01	68682002301	1000 TABLET in 1 BOTTLE (68682-023-01)	1000 tablet	2020-10-02	0000-00-00	No	No	Current
68682-023-10	68682002310	100 TABLET in 1 BOTTLE (68682-023-10)	100 tablet	2020-10-02	0000-00-00	No	No	Current
68682-023-50	68682002350	500 TABLET in 1 BOTTLE (68682-023-50)	500 tablet	2020-10-02	0000-00-00	No	No	Current
68682-023-90	68682002390	90 TABLET in 1 BOTTLE (68682-023-90)	90 tablet	2020-10-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methazolamide Tablets USP 25 mg and 50 mg Rx only	Oceanside Pharmaceuticals \| Micro Labs Limited	2020-04-01	HUMAN PRESCRIPTION DRUG LABEL	1