Home NDC 51672-1292 Hydrocortisone Valerate
Product NDC 51672-1292
11-digit product format 516721292
Labeler code 51672
Product ID 51672-1292_39628349-b388-4030-e063-6394a90a6ce9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone Valerate
Dosage form OINTMENT
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA075043
Marketing category ANDA
Marketing start 1998-08-25
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 A075043-001 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075043-001 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 · 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 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075043-001 HYDROCORTISONE VALERATE 0.2% OINTMENT / TOPICAL AB RS 1998-08-25 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1370750 Internal RxNorm lookup 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 51672-1292-1 Hydrocortisone Valerate 1 in 1 CARTON OINTMENT 1 7 51672-1292-1 Hydrocortisone Valerate 15 g in 1 TUBE OINTMENT 15 7 51672-1292-3 Hydrocortisone Valerate 1 in 1 CARTON OINTMENT 1 7 51672-1292-3 Hydrocortisone Valerate 60 g in 1 TUBE OINTMENT 60 7 51672-1292-6 Hydrocortisone Valerate 1 in 1 CARTON OINTMENT 1 7 51672-1292-6 Hydrocortisone Valerate 45 g in 1 TUBE OINTMENT 45 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydrocortisone Valerate ACTIVE INGREDIENT 68717P8FUZ HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 Hydrocortisone ACTIVE MOIETY WI4X0X7BPJ HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 carbomer homopolymer type b (allyl pentaerythritol crosslinked) INACTIVE INGREDIENT HHT01ZNK31 HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 carbomer homopolymer type c (allyl pentaerythritol crosslinked) INACTIVE INGREDIENT 4Q93RCW27E HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 methylparaben INACTIVE INGREDIENT A2I8C7HI9T HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 mineral oil INACTIVE INGREDIENT T5L8T28FGP HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 petrolatum INACTIVE INGREDIENT 4T6H12BN9U HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 sodium phosphate, dibasic INACTIVE INGREDIENT GR686LBA74 HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 steareth-100 INACTIVE INGREDIENT 4OH5W9UM87 HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 3 HYDROCORTISONE VALERATE ACTIVE INGREDIENT 68717P8FUZ HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 CARBOMER HOMOPOLYMER TYPE B INACTIVE INGREDIENT HHT01ZNK31 HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 CARBOMER HOMOPOLYMER TYPE C INACTIVE INGREDIENT 4Q93RCW27E HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 STEARETH-100 INACTIVE INGREDIENT 4OH5W9UM87 HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 STEARETH-2 INACTIVE INGREDIENT V56DFE46J5 HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1292 HYDROCORTISONE VALERATE CREAM HYDROCORTISONE VALERATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 6 Current NDC, Legacy NDC, 6 package rows 20230129_a9011d6f-6808-48a7-ab6b-df8d40540570.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 51672-1292-1 51672129201 1 TUBE in 1 CARTON (51672-1292-1) / 15 g in 1 TUBE 1 tube 1998-08-25 0000-00-00 No No Current 51672-1292-3 51672129203 1 TUBE in 1 CARTON (51672-1292-3) / 60 g in 1 TUBE 1 tube 1998-08-25 0000-00-00 No No Current 51672-1292-6 51672129206 1 TUBE in 1 CARTON (51672-1292-6) / 45 g in 1 TUBE 1 tube 1998-08-25 0000-00-00 No No Current