Home NDC 51672-4061 Hydrocortisone Butyrate
Product NDC 51672-4061
11-digit product format 516724061
Labeler code 51672
Product ID 51672-4061_26e4c766-6315-4c55-9814-181258a45ad5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone Butyrate
Dosage form SOLUTION
Route TOPICAL
Labeler Taro Pharmaceuticals U.S.A., Inc.
Application ANDA076364
Marketing category ANDA
Marketing start 2004-01-14
Substance HYDROCORTISONE BUTYRATE
Active strength 1 mg/mL
Pharmacologic classes 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 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 A076364-001 HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076364-001 AT
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 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076364-001 HYDROCORTISONE BUTYRATE 0.1% SOLUTION / TOPICAL AT 2004-01-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone Butyrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE BUTYRATE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 05RMF7YPWN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1370758 Internal RxNorm lookup 1370767 Internal RxNorm lookup 1370770 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 51672-4061-2 Hydrocortisone Butyrate 1 in 1 CARTON SOLUTION 1 5 51672-4061-2 Hydrocortisone Butyrate 20 mL in 1 BOTTLE SOLUTION 20 5 51672-4061-4 Hydrocortisone Butyrate 60 mL in 1 BOTTLE SOLUTION 60 5 51672-4061-4 Hydrocortisone Butyrate 1 in 1 CARTON SOLUTION 1 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydrocortisone Butyrate ACTIVE INGREDIENT 05RMF7YPWN HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 Hydrocortisone ACTIVE MOIETY WI4X0X7BPJ HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 anhydrous citric acid INACTIVE INGREDIENT XF417D3PSL HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 anhydrous trisodium citrate INACTIVE INGREDIENT RS7A450LGA HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 butylparaben INACTIVE INGREDIENT 3QPI1U3FV8 HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 ceteth-20 INACTIVE INGREDIENT I835H2IHHX HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 glycerin INACTIVE INGREDIENT PDC6A3C0OX HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 high density polyethylene INACTIVE INGREDIENT UG00KM4WR7 HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 light mineral oil INACTIVE INGREDIENT N6K5787QVP HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 mineral oil INACTIVE INGREDIENT T5L8T28FGP HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 petrolatum INACTIVE INGREDIENT 4T6H12BN9U HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 povidones INACTIVE INGREDIENT FZ989GH94E HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-4061 HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 4 package rows 20210409_51176835-598d-4da7-8a00-6bd36f52aa82.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 51672-4061-2 51672406102 1 BOTTLE in 1 CARTON (51672-4061-2) / 20 mL in 1 BOTTLE 1 bottle 2004-01-14 0000-00-00 No No Current 51672-4061-4 51672406104 1 BOTTLE in 1 CARTON (51672-4061-4) / 60 mL in 1 BOTTLE 1 bottle 2004-01-14 0000-00-00 No No Current