Home NDC 0168-0080 Hydrocortisone
Product NDC 0168-0080
11-digit product format 001680080
Labeler code 0168
Product ID 0168-0080_d4641721-bb32-4cf7-b17f-78886ffbce17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application ANDA089414
Marketing category ANDA
Marketing start 1986-12-16
Substance HYDROCORTISONE
Active strength 25 mg/g
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 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 A089414-001 HYDROCORTISONE HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A089414-001 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 · 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 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089414-001 HYDROCORTISONE 2.5% CREAM / TOPICAL AT RS 1986-12-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 103401 Internal RxNorm lookup 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 0168-0080-16 Hydrocortisone 454 g in 1 JAR CREAM 454 12 0168-0080-31 Hydrocortisone 30 g in 1 TUBE CREAM 30 12
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0168-0080 HYDROCORTISONE OINTMENT HYDROCORTISONE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] 11 Current NDC, Legacy NDC, 2 package rows 20241204_bcd103f3-3dc8-4394-b8fd-8f8ddb721f77.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 0168-0080-16 00168008016 454 g in 1 JAR (0168-0080-16) 454 g 1996-12-16 0000-00-00 No No Current 0168-0080-31 00168008031 30 g in 1 TUBE (0168-0080-31) 30 g 1986-12-16 0000-00-00 No No Current