Methazolamide

Product NDC: 62559-241
11-digit product format: 625590241
Labeler code: 62559
Product ID: 62559-241_7a4099f0-7e1b-49ae-ae13-1463c08daaa5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methazolamide
Dosage form: TABLET
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA040001
Marketing category: ANDA
Marketing start: 2014-11-06
Substance: METHAZOLAMIDE
Active strength: 50 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 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
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 · 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	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…`
2021-12-28 21:50 UTC	2021-12	A040001-001	METHAZOLAMIDE	25MG	TABLET / ORAL	AB	1993-06-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040001-002	METHAZOLAMIDE	50MG	TABLET / ORAL	AB	1993-06-30	`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	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…`
2021-12-28 21:50 UTC	2021-12	A040001-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040001-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHAZOLAMIDE	50 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
c26c8834-961e-4c9c-9ad4-5db2d9419938	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
62559-241-01	Methazolamide	100 in 1 BOTTLE	TABLET	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62559-241-01	EA - Each	62559-241	d9eb9347-7959-4cdd-a279-6a12bec042ae	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHAZOLAMIDE	ACTIVE INGREDIENT	W733B0S9SD	METHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]	1
METHAZOLAMIDE	ACTIVE MOIETY	W733B0S9SD	METHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]	1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	METHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]	1
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	METHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	METHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	METHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62559-241	METHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 1 package rows	20231216_c26c8834-961e-4c9c-9ad4-5db2d9419938.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 ndc (product): 62559-241
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

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
197940	methazolAMIDE 50 MG Oral Tablet	PSN	1698aa2d-a962-4bcc-8646-4fff532b645b	103
197940	methazolamide 50 MG Oral Tablet	SCD	1698aa2d-a962-4bcc-8646-4fff532b645b	103
197940	methazolAMIDE 50 MG Oral Tablet	PSN	369e89a4-9898-4a9f-a316-17d0fce8a08b	101
197940	methazolamide 50 MG Oral Tablet	SCD	369e89a4-9898-4a9f-a316-17d0fce8a08b	101
197939	methazolAMIDE 25 MG Oral Tablet	PSN	723f830c-a534-55d1-e053-2a91aa0a403c	6
197940	methazolAMIDE 50 MG Oral Tablet	PSN	723f830c-a534-55d1-e053-2a91aa0a403c	6
197939	methazolamide 25 MG Oral Tablet	SCD	723f830c-a534-55d1-e053-2a91aa0a403c	6
197940	methazolamide 50 MG Oral Tablet	SCD	723f830c-a534-55d1-e053-2a91aa0a403c	6
197939	methazolAMIDE 25 MG Oral Tablet	PSN	c26c8834-961e-4c9c-9ad4-5db2d9419938	5
197940	methazolAMIDE 50 MG Oral Tablet	PSN	c26c8834-961e-4c9c-9ad4-5db2d9419938	5
197939	methazolamide 25 MG Oral Tablet	SCD	c26c8834-961e-4c9c-9ad4-5db2d9419938	5
197940	methazolamide 50 MG Oral Tablet	SCD	c26c8834-961e-4c9c-9ad4-5db2d9419938	5
197940	methazolAMIDE 50 MG Oral Tablet	PSN	26ba7e5c-c058-b97e-e063-6394a90a4736	1
197940	methazolamide 50 MG Oral Tablet	SCD	26ba7e5c-c058-b97e-e063-6394a90a4736	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62559-241-01	62559024101	100 TABLET in 1 BOTTLE (62559-241-01)	100 tablet	2014-11-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methazolamide Tablets USP Rx only	Bryant Ranch Prepack	2026-03-27	HUMAN PRESCRIPTION DRUG LABEL	103
Methazolamide Tablets USP Rx only	Bryant Ranch Prepack	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	101
Methazolamide Tablets USP Rx only	Golden State Medical Supply, Inc.	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	6
Methazolamide Tablets USP Rx only	ANI Pharmaceuticals, Inc.	2025-11-26	HUMAN PRESCRIPTION DRUG LABEL	5
Methazolamide Tablets USP Rx only	Coupler LLC	2024-11-12	HUMAN PRESCRIPTION DRUG LABEL	1