Methazolamide

Product NDC
27241-246
11-digit product format
272410246
Labeler code
27241
Product ID
27241-246_924990c8-715d-4601-87af-e27fde11f70b
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 44.

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
2026-10-15 13:18:302026-09A217408-001METHAZOLAMIDE25MGTABLET / ORALAB2026-02-09c2088c7a36db…
2026-10-15 13:18:302026-09A217408-002METHAZOLAMIDE50MGTABLET / ORALAB2026-02-09c2088c7a36db…
2026-09-14 22:38:342026-08A217408-001METHAZOLAMIDE25MGTABLET / ORALAB2026-02-0984e616aacf4f…
2026-09-14 22:38:342026-08A217408-002METHAZOLAMIDE50MGTABLET / ORALAB2026-02-0984e616aacf4f…
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
2026-10-15 13:18:302026-09A217408-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A217408-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08A217408-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A217408-002AB184e616aacf4f…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHAZOLAMIDE25 mg/1

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

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