Home NDC 0713-0560 Hydrocortisone Valerate
Product NDC 0713-0560
11-digit product format 007130560
Labeler code 0713
Product ID 0713-0560_0b46d11e-449c-315b-e063-6294a90a6e2a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCORTISONE VALERATE
Dosage form OINTMENT
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA211764
Marketing category ANDA
Marketing start 2021-05-03
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 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 A211764-001 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211764-001 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 2026-08-18 06:07:40 2026-07 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211764-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB 2020-03-04 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone Valerate
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 1370750 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 0713-0560-15 Hydrocortisone Valerate 1 in 1 CARTON OINTMENT 1 4 0713-0560-15 Hydrocortisone Valerate 15 g in 1 TUBE OINTMENT 15 4 0713-0560-37 Hydrocortisone Valerate 45 g in 1 TUBE OINTMENT 45 4 0713-0560-37 Hydrocortisone Valerate 1 in 1 CARTON OINTMENT 1 4 0713-0560-60 Hydrocortisone Valerate 60 g in 1 TUBE OINTMENT 60 4 0713-0560-60 Hydrocortisone Valerate 1 in 1 CARTON OINTMENT 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0560 HYDROCORTISONE VALERATE OINTMENT [COSETTE PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 6 package rows 20231130_1cb06573-1ac8-4dfe-8123-00bbd20a1650.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 0713-0560-15 00713056015 1 TUBE in 1 CARTON (0713-0560-15) / 15 g in 1 TUBE 1 tube 2021-05-03 0000-00-00 No No Current 0713-0560-37 00713056037 1 TUBE in 1 CARTON (0713-0560-37) / 45 g in 1 TUBE 1 tube 2021-05-03 0000-00-00 No No Current 0713-0560-60 00713056060 1 TUBE in 1 CARTON (0713-0560-60) / 60 g in 1 TUBE 1 tube 2021-05-03 0000-00-00 No No Current