Methazolamide

Product NDC
27241-246
11-digit product format
272410246
Labeler code
27241
Product ID
27241-246_a9e7c170-285c-4591-9a4f-0166806831dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methazolamide
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA217408
Marketing category
ANDA
Marketing start
2026-02-09
Substance
METHAZOLAMIDE
Active strength
25 mg/1
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 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
A217408-001METHAZOLAMIDEMETHAZOLAMIDE25MGTABLET / ORALAB2026-02-09
A217408-002METHAZOLAMIDEMETHAZOLAMIDE50MGTABLET / ORALAB2026-02-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217408-001AB
A217408-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A217408-001METHAZOLAMIDE25MGTABLET / ORALAB2026-02-09caaa826d4ba7…
2026-08-18 06:07:402026-07A217408-002METHAZOLAMIDE50MGTABLET / ORALAB2026-02-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217408-001METHAZOLAMIDE25MGTABLET / ORALAB2026-02-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217408-002METHAZOLAMIDE50MGTABLET / ORALAB2026-02-09011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217408-001METHAZOLAMIDE25MGTABLET / ORALAB2026-02-09a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217408-002METHAZOLAMIDE50MGTABLET / ORALAB2026-02-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A217408-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217408-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217408-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217408-002AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217408-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217408-002AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHAZOLAMIDE25 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
879a3c78-24dd-41f9-8fce-5f3166b0e2f4Available 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
27241-246-01Methazolamide100 in 1 BOTTLETABLET1003

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethazolamideMETHAZOLAMIDEAjanta Pharma USA Inc.879a3c78-24dd-41f9-8fce-5f3166b0e2f42026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217408
application number: ANDA217408
ndc (product): 27241-246

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197939methazolAMIDE 25 MG Oral TabletPSN879a3c78-24dd-41f9-8fce-5f3166b0e2f43
197940methazolAMIDE 50 MG Oral TabletPSN879a3c78-24dd-41f9-8fce-5f3166b0e2f43
197939methazolamide 25 MG Oral TabletSCD879a3c78-24dd-41f9-8fce-5f3166b0e2f43
197940methazolamide 50 MG Oral TabletSCD879a3c78-24dd-41f9-8fce-5f3166b0e2f43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27241-246-0127241024601100 TABLET in 1 BOTTLE (27241-246-01) 100 tablet2026-02-09NoNoCurrent