Home NDC 0168-0180-15 Desoximetasone
Product NDC 0168-0180
Requested package NDC 0168-0180-15
11-digit product format 001680180
Labeler code 0168
Product ID 0168-0180_3e7ef6cc-659b-4f69-ac46-905fa237d2e8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desoximetasone
Dosage form CREAM
Route TOPICAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application ANDA078369
Marketing category ANDA
Marketing start 2010-06-29
Marketing end 0000-00-00
Substance DESOXIMETASONE
Active strength 3 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 A078369-001 DESOXIMETASONE DESOXIMETASONE 0.25% CREAM / TOPICAL AB 2010-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078369-001 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.
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 2026-08-01 22:54:32 2026-06 A078369-001 DESOXIMETASONE 0.25% CREAM / TOPICAL AB 2010-06-29 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A078369-001 AB 1 a50c72e98297…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DESOXIMETASONE ACTIVE INGREDIENT 4E07GXB7AU DESOXIMETASONE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 DESOXIMETASONE ACTIVE MOIETY 4E07GXB7AU DESOXIMETASONE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S DESOXIMETASONE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS DESOXIMETASONE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 LANOLIN ALCOHOLS INACTIVE INGREDIENT 884C3FA9HE DESOXIMETASONE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP DESOXIMETASONE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U DESOXIMETASONE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R DESOXIMETASONE CREAM [E. FOUGERA & CO., A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0168-0180-15 00168018015 1 TUBE in 1 CARTON (0168-0180-15) > 15 g in 1 TUBE 1 tube 2010-06-29 0000-00-00 No No Current