FDA.reportPublic FDA data

Mometasone Furoate

Product NDC
85766-181
Requested package NDC
85766-181-15
11-digit product format
857660181
Labeler code
85766
Product ID
85766-181_4d5a0ff2-12f8-e8f2-e063-6394a90a701c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mometasone Furoate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sportpharm LLC
Application
ANDA076067
Marketing category
ANDA
Marketing start
2008-07-18
Substance
MOMETASONE FUROATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 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
A076067-001MOMETASONE FUROATEMOMETASONE FUROATE0.1%OINTMENT / TOPICALABRS2002-03-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076067-001AB

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 22:54:322026-06A076067-001MOMETASONE FUROATE0.1%OINTMENT / TOPICALABRS2002-03-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076067-001AB1a50c72e98297…

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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mometasone FuroateMOMETASONE FUROATEPreferred Pharmaceuticals Inc.bfe3d098-a5f8-4e5d-9fa6-eac167bad3e92026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack5eda1256-001a-4f40-b3ca-15349d5320332026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATESportpharm LLCf02dea3f-9e4f-4c5a-bea3-f428afca803b2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
ndc (package): 85766-181-15
ndc (product): 85766-181
ndc11 (package): 85766018115
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack43a91066-1d85-4f67-9856-a11c1bb2b22b2024-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepack45c9512b-9463-4684-bfdb-742644d77cc32024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepackc3053a64-9044-496e-9005-12b4440d46e82023-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEBryant Ranch Prepacka6055a9c-e19c-48ad-a743-c0a7f7366cdd2023-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEA-S Medication Solutions9fe65193-b4d8-480b-89b3-178cd1b207132023-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEPadagis Israel Pharmaceuticals Ltdd986282f-da3c-43b6-a3f6-40886d4a19152023-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067
Mometasone FuroateMOMETASONE FUROATEProficient Rx LPc08fcb0d-7fff-4d90-aeb8-e912b930bf3d2020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076067
application number: ANDA076067

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOMETASONE FUROATE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04201GDN4RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
151029Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f02dea3f-9e4f-4c5a-bea3-f428afca803bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
1cbe9071-502b-482d-9c24-839b43446576Product name120200123
ce567bde-218c-2386-f79b-42addb0c34fbProduct name220180829
1e8b10fc-5c6a-4af6-9363-4bda9402a4f4Product name120180209
fa8c1c3a-f36c-46b1-b4f1-4e877f3dcb1dProduct name220170613
511188c3-b8c1-4966-aa31-5463cfd4fa48Product name120141222
6dcdf27c-6d6a-2465-ccae-faeb308e8070Product name120140508
aca60174-7f12-2753-ec74-0eb827cf0776Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85766-181-15Mometasone Furoate1 in 1 CARTONOINTMENT11
85766-181-15Mometasone Furoate15 g in 1 TUBEOINTMENT151

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151029mometasone furoate 0.1 % Topical OintmentPSNf02dea3f-9e4f-4c5a-bea3-f428afca803b1
151029mometasone furoate 0.001 MG/MG Topical OintmentSCDf02dea3f-9e4f-4c5a-bea3-f428afca803b1
151029mometasone furoate 0.1 % Topical OintmentSYf02dea3f-9e4f-4c5a-bea3-f428afca803b1
151029mometasone furoate 1 MG/GM Topical OintmentSYf02dea3f-9e4f-4c5a-bea3-f428afca803b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-181-15857660181151 TUBE in 1 CARTON (85766-181-15) / 15 g in 1 TUBE1 tube2026-03-19NoNoCurrent