Home NDC 63629-9585-1 Testosterone Gel, 1%
Product NDC 63629-9585
Requested package NDC 63629-9585-1
11-digit product format 636299585
Labeler code 63629
Product ID 63629-9585_431f2447-ef1d-4d4a-9091-8e979b74571e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Testosterone Gel, 1%
Dosage form GEL
Route TRANSDERMAL
Labeler Bryant Ranch Prepack
Application ANDA212984
Marketing category ANDA
Marketing start 2021-11-19
Marketing end 0000-00-00
Substance TESTOSTERONE
Active strength 10 mg/g
Pharmacologic classes Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2023-12-31
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 · 11 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A212984-001 TESTOSTERONE TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 A212984-002 TESTOSTERONE TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 A212984-003 TESTOSTERONE TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 57 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 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212984-003 TESTOSTERONE 25MG/2.5GM PACKET GEL / TRANSDERMAL AB1 2024-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212984-002 TESTOSTERONE 12.5MG/1.25GM ACTUATION GEL, METERED / TRANSDERMAL AB1 2024-02-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212984-001 TESTOSTERONE 50MG/5GM PACKET GEL / TRANSDERMAL AB1 2021-11-09 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 57 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 · 2 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Testosterone Gel, 1% TESTOSTERONE GEL, 1% Bryant Ranch Prepack 353de205-d642-4f26-875b-b9ea4707a755 2026-04-07 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212984 application number: ANDA212984 Testosterone Gel, 1% TESTOSTERONE GEL, 1% Encube Ethicals, Inc. 7d655d6d-01da-488c-bd4e-c7fbe0ace38c 2025-10-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 212984 application number: ANDA212984
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-9585-1 63629958501 30 PACKET in 1 CARTON (63629-9585-1) > 5 g in 1 PACKET 30 packet 2022-12-12 0000-00-00 No No Current