FDA.reportPublic FDA data

Clotrimazole

Product NDC
67296-2252
Requested package NDC
67296-2252-3
11-digit product format
672962252
Labeler code
67296
Product ID
67296-2252_53cb3b8e-e8d2-fffc-e063-6294a90ac814
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Redpharm Drug
Application
ANDA090219
Marketing category
ANDA
Marketing start
2010-08-04
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC]; Azoles [CS]
Listing certified through
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090219-001CLOTRIMAZOLECLOTRIMAZOLE1%CREAM / TOPICALAB2010-08-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090219-001AB

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
2026-08-01 22:54:322026-06A090219-001CLOTRIMAZOLE1%CREAM / TOPICALAB2010-08-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090219-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLERedpharm Drug53cafc9f-7761-83a9-e063-6294a90a34372026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090219
application number: ANDA090219
ndc (package): 67296-2252-3
ndc (product): 67296-2252
ndc11 (package): 67296225203
ClotrimazoleCLOTRIMAZOLEGlenmark Pharmaceuticals Inc., USAf6898117-14f3-42d2-bc0e-d296add3ad702026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090219
application number: ANDA090219
ClotrimazoleCLOTRIMAZOLEA-S Medication Solutions116be3a8-9a57-4b4a-a873-98a4ce83bcf72025-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090219
application number: ANDA090219

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309367Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53cafc9f-7761-83a9-e063-6294a90a3437Available on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
67296-2252-36729622520330 g in 1 TUBE (67296-2252-3)30 g2010-08-040Current