Home NDC 50383-270 Clobetasol Propionate
Product NDC 50383-270
11-digit product format 503830270
Labeler code 50383
Product ID 50383-270_552f5be6-bc56-4f8d-99c0-16d3de609ef4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clobetasol Propionate
Dosage form EMULSION
Route TOPICAL
Labeler Akorn
Application ANDA075325
Marketing category ANDA
Marketing start 2010-06-07
Marketing end 0000-00-00
Substance CLOBETASOL PROPIONATE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A075325-001 EMBELINE E CLOBETASOL PROPIONATE 0.05% CREAM / TOPICAL 1998-12-24
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 · 43 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 2026-09-14 22:38:34 2026-08 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL AB2 1998-12-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075325-001 EMBELINE E 0.05% CREAM / TOPICAL 1998-12-24 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 CETETH-20 INACTIVE INGREDIENT I835H2IHHX CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 DIMETHICONE 350 INACTIVE INGREDIENT 2Y53S6ATLU CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 IMIDUREA INACTIVE INGREDIENT M629807ATL CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE EMULSION [HI-TECH PHARMACAL CO., INC.] 2 CLOBETASOL PROPIONATE ACTIVE INGREDIENT 779619577M CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 CLOBETASOL ACTIVE MOIETY ADN79D536H CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 CETETH-20 INACTIVE INGREDIENT I835H2IHHX CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 DIMETHICONE 350 INACTIVE INGREDIENT 2Y53S6ATLU CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 IMIDUREA INACTIVE INGREDIENT M629807ATL CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CLOBETASOL PROPIONATE EMULSION [PHYSICIANS TOTAL CARE, INC.] 1
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 50383-270-15 50383027015 1 TUBE in 1 CARTON (50383-270-15) > 15 g in 1 TUBE 1 tube 2010-06-07 0000-00-00 No No Current 50383-270-30 50383027030 1 TUBE in 1 CAPSULE (50383-270-30) > 30 g in 1 TUBE 1 tube 2010-06-07 0000-00-00 No No Current 50383-270-60 50383027060 1 TUBE in 1 CARTON (50383-270-60) > 60 g in 1 TUBE 1 tube 2010-06-07 0000-00-00 No No Current