Home NDC 68180-951 Hydrocortisone Butyrate
Product NDC 68180-951
11-digit product format 681800951
Labeler code 68180
Product ID 68180-951_ae94a872-5187-4e85-b573-5e9ee9610bff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone Butyrate
Dosage form LOTION
Route TOPICAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA210209
Marketing category ANDA
Marketing start 2018-08-17
Substance HYDROCORTISONE BUTYRATE
Active strength 1 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A210209-001 HYDROCORTISONE BUTYRATE HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB RS 2018-08-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210209-001 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.
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 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB RS 2018-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB RS 2018-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB RS 2018-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB RS 2018-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB RS 2018-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB RS 2018-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB RS 2018-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB RS 2018-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB RS 2018-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB RS 2018-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210209-001 HYDROCORTISONE BUTYRATE 0.1% LOTION / TOPICAL AB 2018-08-17 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1370763 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 68180-951-01 Hydrocortisone Butyrate 59 mL in 1 BOTTLE LOTION 59 7 68180-951-01 Hydrocortisone Butyrate 1 in 1 CARTON LOTION 1 7 68180-951-02 Hydrocortisone Butyrate 118 mL in 1 BOTTLE LOTION 118 7 68180-951-02 Hydrocortisone Butyrate 1 in 1 CARTON LOTION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-951 HYDROCORTISONE BUTYRATE LOTION [LUPIN PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 4 package rows 20250201_275f3fcf-1170-4df0-9a8d-1482bda409cb.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 68180-951-01 68180095101 1 BOTTLE in 1 CARTON (68180-951-01) / 59 mL in 1 BOTTLE 1 bottle 2018-08-17 0000-00-00 No No Current 68180-951-02 68180095102 1 BOTTLE in 1 CARTON (68180-951-02) / 118 mL in 1 BOTTLE 1 bottle 2018-08-17 0000-00-00 No No Current