Home NDC 63187-480 Hydrocortisone
Product NDC 63187-480
11-digit product format 631870480
Labeler code 63187
Product ID 63187-480_8335b16b-0981-4efd-88f7-c3999bbaef04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Proficient Rx LP
Application ANDA089682
Marketing category ANDA
Marketing start 2002-09-30
Substance HYDROCORTISONE
Active strength 25 mg/g
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 42 .
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 A089682-001 HYDROCORTISONE HYDROCORTISONE 2.5% CREAM / TOPICAL 1988-03-10
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 · 42 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 2026-08-18 06:07:40 2026-07 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL 1988-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089682-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1988-03-10 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 25 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310891 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 63187-480-20 Hydrocortisone 1 in 1 CARTON CREAM 1 6 63187-480-20 Hydrocortisone 20 g in 1 TUBE CREAM 20 6 63187-480-30 Hydrocortisone 30 g in 1 TUBE CREAM 30 6 63187-480-30 Hydrocortisone 1 in 1 CARTON CREAM 1 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-480 HYDROCORTISONE CREAM [PROFICIENT RX LP] 6 Current NDC, Legacy NDC, 4 package rows 20220728_d50240db-f630-4008-a272-55ba5c991304.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 · 3 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 63187-480-20 63187048020 1 TUBE in 1 CARTON (63187-480-20) / 20 g in 1 TUBE 1 tube 2018-12-01 0000-00-00 No No Current 63187-480-30 63187048030 1 TUBE in 1 CARTON (63187-480-30) / 30 g in 1 TUBE 1 tube 2018-12-01 0000-00-00 No No Current