Home NDC 16781-384-45 Locoid Lipocream
Product NDC 16781-384
Requested package NDC 16781-384-45
11-digit product format 167810384
Labeler code 16781
Product ID 16781-384_d087a8ef-b68a-49f2-a4db-e708a49addc1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name HYDROCORTISONE BUTYRATE
Dosage form CREAM
Route TOPICAL
Labeler Bausch Health US, LLC
Application NDA020769
Marketing category NDA
Marketing start 2013-07-03
Marketing end 0000-00-00
Substance HYDROCORTISONE BUTYRATE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 16781-384 16781-384-45 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 16781-384 16781-384-45 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 16781-384 16781-384-45 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 16781-384 16781-384-45 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 16781-384 16781-384-45 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 16781-384 16781-384-45 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 16781-384 16781-384-45 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 16781-384 16781-384-45 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 16781-384 16781-384-45 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 16781-384 16781-384-45 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…
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.
DailyMed Socrata Ingredients# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16781-384-45 16781038445 1 TUBE in 1 CARTON (16781-384-45) > 45 g in 1 TUBE 1 tube 2013-07-03 0000-00-00 No No Current