Methazolamide

Product NDC
51407-027
11-digit product format
514070027
Labeler code
51407
Product ID
51407-027_45b1436a-370d-c6a3-e063-6294a90ab13b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methazolamide
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA040001
Marketing category
ANDA
Marketing start
1993-06-30
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040001-001METHAZOLAMIDEMETHAZOLAMIDE25MGTABLET / ORALAB1993-06-30
A040001-002METHAZOLAMIDEMETHAZOLAMIDE50MGTABLET / ORALAB1993-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040001-001AB
A040001-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040001-001METHAZOLAMIDE25MGTABLET / ORALAB1993-06-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040001-002METHAZOLAMIDE50MGTABLET / ORALAB1993-06-30bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040001-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040001-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040001-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040001-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040001-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040001-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040001-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040001-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040001-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040001-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040001-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040001-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040001-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040001-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040001-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040001-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040001-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040001-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040001-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040001-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040001-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040001-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040001-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040001-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040001-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040001-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040001-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040001-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040001-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040001-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040001-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040001-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040001-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040001-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040001-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040001-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040001-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040001-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040001-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040001-002AB1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHAZOLAMIDE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W733B0S9SDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197939Internal RxNorm lookup
197940Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
723f830c-a534-55d1-e053-2a91aa0a403cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a1f610d4-6674-3a87-200e-f2590485d943Product name320231221

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-027-01Methazolamide100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-027-01EA - Each51407-027b4b7f46a-4c66-41be-a09f-168392692e5d12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-027METHAZOLAMIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]5Current NDC, Legacy NDC, 1 package rows20241228_723f830c-a534-55d1-e053-2a91aa0a403c.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethazolamideMETHAZOLAMIDEBryant Ranch Prepackff710572-ed62-490a-95f1-2b2c2eed08ee2026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040001
application number: ANDA040001
MethazolamideMETHAZOLAMIDEBryant Ranch Prepack1698aa2d-a962-4bcc-8646-4fff532b645b2026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040001
application number: ANDA040001
MethazolamideMETHAZOLAMIDEBryant Ranch Prepack504b695a-ac9e-4c71-8755-d31f1958a71c2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040001
application number: ANDA040001
MethazolamideMETHAZOLAMIDEBryant Ranch Prepack369e89a4-9898-4a9f-a316-17d0fce8a08b2026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040001
application number: ANDA040001
MethazolamideMETHAZOLAMIDEGolden State Medical Supply, Inc.723f830c-a534-55d1-e053-2a91aa0a403c2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040001
application number: ANDA040001
ndc (product): 51407-027
MethazolamideMETHAZOLAMIDEANI Pharmaceuticals, Inc.c26c8834-961e-4c9c-9ad4-5db2d94199382025-11-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040001
application number: ANDA040001
MethazolamideMETHAZOLAMIDENorthStar Rx LLC042586b3-4d49-c5ae-e063-6394a90aaa7c2023-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040001
application number: ANDA040001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197939methazolAMIDE 25 MG Oral TabletPSN723f830c-a534-55d1-e053-2a91aa0a403c6
197940methazolAMIDE 50 MG Oral TabletPSN723f830c-a534-55d1-e053-2a91aa0a403c6
197939methazolamide 25 MG Oral TabletSCD723f830c-a534-55d1-e053-2a91aa0a403c6
197940methazolamide 50 MG Oral TabletSCD723f830c-a534-55d1-e053-2a91aa0a403c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-027-0151407002701100 TABLET in 1 BOTTLE (51407-027-01) 100 tablet2018-01-010000-00-00NoNoCurrent