Home NDC 0713-0635 Mometasone Furoate
Product NDC 0713-0635
11-digit product format 007130635
Labeler code 0713
Product ID 0713-0635_0b4770a7-60b1-f27f-e063-6394a90a16a6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mometasone Furoate
Dosage form OINTMENT
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA077401
Marketing category ANDA
Marketing start 2014-03-04
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 2026-12-31
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077401-001 MOMETASONE FUROATE MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077401-001 AB
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 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Mometasone Furoate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOMETASONE FUROATE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 04201GDN4R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 151029 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0713-0635-15 Mometasone Furoate 1 in 1 CARTON OINTMENT 1 8 0713-0635-15 Mometasone Furoate 15 g in 1 TUBE OINTMENT 15 8 0713-0635-37 Mometasone Furoate 1 in 1 CARTON OINTMENT 1 8 0713-0635-37 Mometasone Furoate 45 g in 1 TUBE OINTMENT 45 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Mometasone Furoate ACTIVE INGREDIENT 04201GDN4R MOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.] 2 MOMETASONE FUROATE ACTIVE INGREDIENT 04201GDN4R MOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 2 Mometasone ACTIVE MOIETY 8HR4QJ6DW8 MOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.] 2 MOMETASONE FUROATE ACTIVE MOIETY 04201GDN4R MOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 2 Hexylene Glycol INACTIVE INGREDIENT KEH0A3F75J MOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.] 2 HEXYLENE GLYCOL INACTIVE INGREDIENT KEH0A3F75J MOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 2 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U MOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.] 2 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U MOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 2 Phosphoric Acid INACTIVE INGREDIENT E4GA8884NN MOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.] 2 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN MOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 2 PROPYLENE GLYCOL MONOSTEARATE INACTIVE INGREDIENT F76354LMGR MOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 2 Propylene Glycol Stearate INACTIVE INGREDIENT MZM1I680W0 MOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.] 2 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y MOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 2 Water INACTIVE INGREDIENT 059QF0KO0R MOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R MOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 2 WHITE WAX INACTIVE INGREDIENT 7G1J5DA97F MOMETASONE FUROATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 2 White Wax INACTIVE INGREDIENT 7G1J5DA97F MOMETASONE FUROATE (MOMETASONE FUROATE) OINTMENT [G&W LABORATORIES, INC.] 2 Mometasone Furoate ACTIVE INGREDIENT 04201GDN4R MOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 Mometasone Furoate ACTIVE INGREDIENT 04201GDN4R MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Mometasone Furoate ACTIVE MOIETY 04201GDN4R MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Mometasone Furoate ACTIVE MOIETY 04201GDN4R MOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 Hexylene Glycol INACTIVE INGREDIENT KEH0A3F75J MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Hexylene Glycol INACTIVE INGREDIENT KEH0A3F75J MOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Petrolatum INACTIVE INGREDIENT 4T6H12BN9U MOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 Phosphoric Acid INACTIVE INGREDIENT E4GA8884NN MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Phosphoric Acid INACTIVE INGREDIENT E4GA8884NN MOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 Propylene Glycol Monopalmitostearate INACTIVE INGREDIENT F76354LMGR MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 PROPYLENE GLYCOL MONOPALMITOSTEARATE INACTIVE INGREDIENT F76354LMGR MOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y MOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP MOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 Water INACTIVE INGREDIENT 059QF0KO0R MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R MOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP] 1 White Wax INACTIVE INGREDIENT 7G1J5DA97F MOMETASONE FUROATE OINTMENT [DISPENSING SOLUTIONS, INC.] 1 White Wax INACTIVE INGREDIENT 7G1J5DA97F MOMETASONE FUROATE OINTMENT [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0635 MOMETASONE FUROATE OINTMENT [COSETTE PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 4 package rows 20231130_f5b30e5e-b067-e28c-b7c5-aa58f4c57f09.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0713-0635-15 00713063515 1 TUBE in 1 CARTON (0713-0635-15) / 15 g in 1 TUBE 1 tube 2014-03-04 0000-00-00 No No Current 0713-0635-37 00713063537 1 TUBE in 1 CARTON (0713-0635-37) / 45 g in 1 TUBE 1 tube 2014-03-04 0000-00-00 No No Current