Home NDC 68682-384 Hydrocortisone Butyrate
Product NDC 68682-384
11-digit product format 686820384
Labeler code 68682
Product ID 68682-384_36d82d8e-8303-bf39-e063-6394a90a2fab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCORTISONE BUTYRATE
Dosage form CREAM
Route TOPICAL
Labeler Oceanside Pharmaceuticals
Application NDA020769
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2013-07-03
Substance HYDROCORTISONE BUTYRATE
Active strength 1 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 N020769-001 LOCOID LIPOCREAM HYDROCORTISONE BUTYRATE 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020769-001 AB2
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 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020769-001 LOCOID LIPOCREAM 0.1% CREAM / TOPICAL AB2 RLD, RS 1997-09-08 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
Additional Listing Data#
Finished product Yes
Brand name base Hydrocortisone Butyrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE BUTYRATE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 05RMF7YPWN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1370770 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 68682-384-45 Hydrocortisone Butyrate 45 g in 1 TUBE CREAM 45 7 68682-384-45 Hydrocortisone Butyrate 1 in 1 CARTON CREAM 1 7 68682-384-60 Hydrocortisone Butyrate 1 in 1 CARTON CREAM 1 7 68682-384-60 Hydrocortisone Butyrate 60 g in 1 TUBE CREAM 60 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68682-384 HYDROCORTISONE BUTYRATE CREAM [OCEANSIDE PHARMACEUTICALS] 6 Current NDC, Legacy NDC, 4 package rows 20241222_ddf699f4-1ae0-48c3-8d2a-56aa1a2c5bc1.zip
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 68682-384-45 68682038445 1 TUBE in 1 CARTON (68682-384-45) / 45 g in 1 TUBE 1 tube 2013-07-03 0000-00-00 No No Current 68682-384-60 68682038460 1 TUBE in 1 CARTON (68682-384-60) / 60 g in 1 TUBE 1 tube 2013-07-03 0000-00-00 No No Current