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 42 .
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 · 42 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 2026-08-18 06:07:40 2026-07 A077401-001 MOMETASONE FUROATE 0.1% OINTMENT / TOPICAL AB 2006-06-20 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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
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.
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