Home NDC 21922-007 hydrocortisone valerate cream
Product NDC 21922-007
11-digit product format 219220007
Labeler code 21922
Product ID 21922-007_85b1a924-1037-419a-a141-878a1539f013
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocortisone valerate cream
Dosage form CREAM
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA211047
Marketing category ANDA
Marketing start 2022-12-31
Substance HYDROCORTISONE VALERATE
Active strength 2 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 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 A211047-001 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211047-001 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.
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 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211047-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB 2021-11-04 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base hydrocortisone valerate cream
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE VALERATE 2 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 68717P8FUZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1370754 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 21922-007-04 hydrocortisone valerate cream 15 g in 1 TUBE CREAM 15 6 21922-007-04 hydrocortisone valerate cream 1 in 1 CARTON CREAM 1 6 21922-007-06 hydrocortisone valerate cream 45 g in 1 TUBE CREAM 45 6 21922-007-06 hydrocortisone valerate cream 1 in 1 CARTON CREAM 1 6 21922-007-07 hydrocortisone valerate cream 60 g in 1 TUBE CREAM 60 6 21922-007-07 hydrocortisone valerate cream 1 in 1 CARTON CREAM 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-007 HYDROCORTISONE VALERATE CREAM CREAM [ENCUBE ETHICALS PRIVATE LIMITED] 5 Current NDC, Legacy NDC, 6 package rows 20241226_41723504-b2cf-4074-9c3a-e3c59bb48c98.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 · 4 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 21922-007-04 21922000704 1 TUBE in 1 CARTON (21922-007-04) / 15 g in 1 TUBE 1 tube 2022-12-31 0000-00-00 No No Current 21922-007-06 21922000706 1 TUBE in 1 CARTON (21922-007-06) / 45 g in 1 TUBE 1 tube 2022-12-31 0000-00-00 No No Current 21922-007-07 21922000707 1 TUBE in 1 CARTON (21922-007-07) / 60 g in 1 TUBE 1 tube 2022-12-31 0000-00-00 No No Current