Home NDC 51672-3004-2 Hydrocortisone
Product NDC 51672-3004
Requested package NDC 51672-3004-2
11-digit product format 516723004
Labeler code 51672
Product ID 51672-3004_5d280132-c8a7-418b-b4fa-d868ef0c1986
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA086155
Marketing category ANDA
Marketing start 2005-04-28
Marketing end 0000-00-00
Substance HYDROCORTISONE
Active strength 10 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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51672-3004 51672-3004-2 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A086155-001 HYDROCORTISONE HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982
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 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A086155-001 HYDROCORTISONE 1% CREAM / TOPICAL Approved before 1982 cb3db0bc1861…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-3004-2 Hydrocortisone 28.35 g in 1 TUBE CREAM 28.35 8 51672-3004-2 Hydrocortisone 1 in 1 CARTON CREAM 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydrocortisone ACTIVE INGREDIENT WI4X0X7BPJ HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 Hydrocortisone ACTIVE MOIETY WI4X0X7BPJ HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 isopropyl palmitate INACTIVE INGREDIENT 8CRQ2TH63M HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 lanolin alcohols INACTIVE INGREDIENT 884C3FA9HE HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 methylparaben INACTIVE INGREDIENT A2I8C7HI9T HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 mineral oil INACTIVE INGREDIENT T5L8T28FGP HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 polyoxyl 40 stearate INACTIVE INGREDIENT 13A4J4NH9I HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 sorbic acid INACTIVE INGREDIENT X045WJ989B HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-3004 HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 5 Legacy NDC, 2 package rows 20231219_e4f22e9c-cf38-473a-8f7d-8da7fd696f76.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 51672-3004-2 51672300402 1 TUBE in 1 CARTON (51672-3004-2) > 28.35 g in 1 TUBE 1 tube 2005-04-28 0000-00-00 No No Current