Home NDC 0254-1012-11 Testosterone
Product NDC 0254-1012
Requested package NDC 0254-1012-11
11-digit product format 002541012
Labeler code 0254
Product ID 0254-1012_7a72cde0-6d26-4af6-b8b1-abe7eac0b447
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name testosterone
Dosage form GEL
Route TRANSDERMAL
Labeler Par Pharmaceutical, Inc.
Application NDA021454
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2017-02-28
Marketing end 2021-09-30
Substance TESTOSTERONE
Active strength 50 mg/5g
Pharmacologic classes Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N021454-001 TESTIM TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021454-001 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 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021454-001 TESTIM 50MG/5GM PACKET GEL / TRANSDERMAL AB2 RLD, RS 2002-10-31 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 241 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Testim TESTOSTERONE Endo USA, Inc. 9f2aae1f-898d-4955-be31-678e0cf85395 2025-07-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021454 application number: NDA021454
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0254-1012-11 00254101211 30 TUBE in 1 CARTON (0254-1012-11) > 5 g in 1 TUBE 30 tube 2017-02-28 2021-09-30 No No Current