Home NDC 64380-801-22 TRIAMCINOLONE ACETONIDE
Product NDC 64380-801
Requested package NDC 64380-801-22
11-digit product format 643800801
Labeler code 64380
Product ID 64380-801_76baadee-0d15-4f24-ad73-7217c80fd657
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TRIAMCINOLONE ACETONIDE
Dosage form CREAM
Route TOPICAL
Labeler Strides Pharma Science Limited
Application ANDA210346
Marketing category ANDA
Marketing start 2019-05-01
Marketing end 0000-00-00
Substance TRIAMCINOLONE ACETONIDE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210346-001 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL 2019-02-11 A210346-002 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL 2019-02-11 A210346-003 TRIAMCINOLONE ACETONIDE TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL 2019-02-11
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 4 · 129 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 2026-09-14 22:38:34 2026-08 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL 2019-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL 2019-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL 2019-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL 2019-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL 2019-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL 2019-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL 2019-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL 2019-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL 2019-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2019-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2019-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2019-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2019-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2019-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2019-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2019-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2019-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2019-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2019-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2019-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2019-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2019-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2019-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2019-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2019-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2019-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2019-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2019-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2019-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2019-02-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2019-02-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2019-02-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2019-02-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2019-02-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2019-02-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2019-02-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2019-02-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210346-002 TRIAMCINOLONE ACETONIDE 0.1% CREAM / TOPICAL AT 2019-02-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210346-003 TRIAMCINOLONE ACETONIDE 0.5% CREAM / TOPICAL AT 2019-02-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210346-001 TRIAMCINOLONE ACETONIDE 0.025% CREAM / TOPICAL AT 2019-02-11 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 117 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64380-801-22 2025-03-28 TRIAMCINOLONE ACETONIDE CREAM USP, 0.025%, 0.1%, 0.5% Rx only 64380-801-23 2025-03-28 TRIAMCINOLONE ACETONIDE CREAM USP, 0.025%, 0.1%, 0.5% Rx only 64380-801-36 2025-03-28 TRIAMCINOLONE ACETONIDE CREAM USP, 0.025%, 0.1%, 0.5% Rx only 64380-801-37 2025-03-28 TRIAMCINOLONE ACETONIDE CREAM USP, 0.025%, 0.1%, 0.5% Rx only 64380-801-22 2024-01-30 TRIAMCINOLONE ACETONIDE CREAM USP, 0.025%, 0.1%, 0.5% Rx only 64380-801-23 2024-01-30 TRIAMCINOLONE ACETONIDE CREAM USP, 0.025%, 0.1%, 0.5% Rx only 64380-801-36 2024-01-30 TRIAMCINOLONE ACETONIDE CREAM USP, 0.025%, 0.1%, 0.5% Rx only 64380-801-37 2024-01-30 TRIAMCINOLONE ACETONIDE CREAM USP, 0.025%, 0.1%, 0.5% Rx only
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64380-801-22 64380080122 1 TUBE in 1 CARTON (64380-801-22) > 15 g in 1 TUBE 1 tube 2019-05-01 0000-00-00 No No Current