Methazolamide

Product NDC: 72603-166
11-digit product format: 726030166
Labeler code: 72603
Product ID: 72603-166_042586b3-4d4a-c5ae-e063-6394a90aaa7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methazolamide
Dosage form: TABLET
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA040001
Marketing category: ANDA
Marketing start: 2023-08-30
Substance: METHAZOLAMIDE
Active strength: 25 mg/1
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 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
A040001-001	METHAZOLAMIDE	METHAZOLAMIDE	25MG	TABLET / ORAL	AB		1993-06-30
A040001-002	METHAZOLAMIDE	METHAZOLAMIDE	50MG	TABLET / ORAL	AB		1993-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040001-001	AB
A040001-002	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	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A040001-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040001-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040001-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040001-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040001-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040001-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040001-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040001-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040001-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040001-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040001-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040001-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040001-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040001-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040001-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040001-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040001-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040001-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040001-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040001-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040001-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040001-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040001-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040001-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040001-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040001-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040001-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040001-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040001-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040001-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040001-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040001-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040001-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040001-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040001-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040001-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040001-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040001-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040001-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040001-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methazolamide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHAZOLAMIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W733B0S9SD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197939	Internal RxNorm lookup
197940	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
042586b3-4d49-c5ae-e063-6394a90aaa7c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a1f610d4-6674-3a87-200e-f2590485d943	Product name	3	20231221

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72603-166-01	Methazolamide	100 in 1 BOTTLE	TABLET	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-166-01	EA - Each	72603-166	e552e90b-298d-4b57-8cbb-7d3cd887232e	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72603-166	METHAZOLAMIDE TABLET [NORTHSTAR RX LLC]	1	Current NDC, 1 package rows	20230914_042586b3-4d49-c5ae-e063-6394a90aaa7c.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methazolamide	METHAZOLAMIDE	Bryant Ranch Prepack	ff710572-ed62-490a-95f1-2b2c2eed08ee	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040001 application number: ANDA040001
Methazolamide	METHAZOLAMIDE	Bryant Ranch Prepack	1698aa2d-a962-4bcc-8646-4fff532b645b	2026-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040001 application number: ANDA040001
Methazolamide	METHAZOLAMIDE	Bryant Ranch Prepack	504b695a-ac9e-4c71-8755-d31f1958a71c	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040001 application number: ANDA040001
Methazolamide	METHAZOLAMIDE	Bryant Ranch Prepack	369e89a4-9898-4a9f-a316-17d0fce8a08b	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040001 application number: ANDA040001
Methazolamide	METHAZOLAMIDE	Golden State Medical Supply, Inc.	723f830c-a534-55d1-e053-2a91aa0a403c	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040001 application number: ANDA040001
Methazolamide	METHAZOLAMIDE	ANI Pharmaceuticals, Inc.	c26c8834-961e-4c9c-9ad4-5db2d9419938	2025-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040001 application number: ANDA040001
Methazolamide	METHAZOLAMIDE	NorthStar Rx LLC	042586b3-4d49-c5ae-e063-6394a90aaa7c	2023-08-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040001 application number: ANDA040001 ndc (product): 72603-166

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197939	methazolAMIDE 25 MG Oral Tablet	PSN	042586b3-4d49-c5ae-e063-6394a90aaa7c	1
197940	methazolAMIDE 50 MG Oral Tablet	PSN	042586b3-4d49-c5ae-e063-6394a90aaa7c	1
197939	methazolamide 25 MG Oral Tablet	SCD	042586b3-4d49-c5ae-e063-6394a90aaa7c	1
197940	methazolamide 50 MG Oral Tablet	SCD	042586b3-4d49-c5ae-e063-6394a90aaa7c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72603-166-01	72603016601	100 TABLET in 1 BOTTLE (72603-166-01)	100 tablet	2023-08-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methazolamide Tablets USP Rx only	NorthStar Rx LLC \| ANI Pharmaceuticals, Inc.	2023-08-30	HUMAN PRESCRIPTION DRUG LABEL	1