Home NDC 51672-3009-2 U-Cort
Product NDC 51672-3009
Requested package NDC 51672-3009-2
11-digit product format 516723009
Labeler code 51672
Product ID 51672-3009_367518ef-8e24-4823-8b29-78002f88aee7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone Acetate
Dosage form CREAM
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA089472
Marketing category ANDA
Marketing start 1988-06-13
Marketing end 0000-00-00
Substance HYDROCORTISONE ACETATE
Active strength 10 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 A089472-001 U-CORT HYDROCORTISONE ACETATE 1% CREAM / TOPICAL 1988-06-13
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 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089472-001 U-CORT 1%;10% CREAM / TOPICAL 1988-06-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089472-001 U-CORT 1%;10% CREAM / TOPICAL 1988-06-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089472-001 U-CORT 1%;10% CREAM / TOPICAL 1988-06-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089472-001 U-CORT 1%;10% CREAM / TOPICAL 1988-06-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089472-001 U-CORT 1% CREAM / TOPICAL 1988-06-13 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydrocortisone Acetate ACTIVE INGREDIENT 3X7931PO74 U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 Hydrocortisone ACTIVE MOIETY WI4X0X7BPJ U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 carbomer homopolymer type c INACTIVE INGREDIENT 4Q93RCW27E U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 edetate disodium INACTIVE INGREDIENT 7FLD91C86K U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 isopropyl myristate INACTIVE INGREDIENT 0RE8K4LNJS U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 isopropyl palmitate INACTIVE INGREDIENT 8CRQ2TH63M U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 sodium metabisulfite INACTIVE INGREDIENT 4VON5FNS3C U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 trolamine INACTIVE INGREDIENT 9O3K93S3TK U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 urea INACTIVE INGREDIENT 8W8T17847W U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 xanthan gum INACTIVE INGREDIENT TTV12P4NEE U-CORT (HYDROCORTISONE ACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-3009-2 51672300902 1 TUBE in 1 CARTON (51672-3009-2) > 28.35 g in 1 TUBE 1 tube 1988-06-13 0000-00-00 No No Current