Home NDC 65649-401 Anusol
Product NDC 65649-401
11-digit product format 656490401
Labeler code 65649
Product ID 65649-401_1103c6ea-1e5c-465c-bae8-9d56dfa9a7cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Salix Pharmaceuticals, Inc
Application ANDA088250
Marketing category ANDA
Marketing start 1984-06-06
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 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 A088250-001 ANUSOL HC HYDROCORTISONE 2.5% CREAM / TOPICAL AT 1984-06-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A088250-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A088250-001 ANUSOL HC 2.5% CREAM / TOPICAL AT 1984-06-06 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Anusol
Brand name suffix HC
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310891 Internal RxNorm lookup 1659445 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 65649-401-30 AnusolHC 30 g in 1 TUBE CREAM 30 9 65649-401-30 AnusolHC 1 in 1 CARTON CREAM 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3 CARBOMER 934 INACTIVE INGREDIENT Z135WT9208 ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3 POLYOXYL 40 STEARATE INACTIVE INGREDIENT 13A4J4NH9I ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3 WATER INACTIVE INGREDIENT 059QF0KO0R ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65649-401 ANUSOL HC (HYDROCORTISONE) CREAM [SALIX PHARMACEUTICALS, INC] 9 Current NDC, Legacy NDC, 2 package rows 20230929_5a0439c8-50a0-4f85-9cb4-9e3a5b0c31e7.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 65649-401-30 65649040130 1 TUBE in 1 CARTON (65649-401-30) / 30 g in 1 TUBE 1 tube 1984-06-06 0000-00-00 No No Current