Testosterone

Product NDC
63629-2124
Requested package NDC
63629-2124-1
11-digit product format
636292124
Labeler code
63629
Product ID
63629-2124_fb529b14-fbe7-4e50-9e3c-38250ca568ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL
Route
TRANSDERMAL
Labeler
Bryant Ranch Prepack
Application
ANDA076744
Marketing category
ANDA
Marketing start
2015-09-02
Marketing end
2024-02-28
Substance
TESTOSTERONE
Active strength
25 mg/2.5g
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-212463629-2124-1DDiscontinued by firm2026-08-17

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076744-001TESTOSTERONETESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-23
A076744-002TESTOSTERONETESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A076744-001AB1
A076744-002AB1

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-23caaa826d4ba7…
2026-08-18 06:07:402026-07A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMAL2007-05-2374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076744-001TESTOSTERONE25MG/2.5GM PACKETGEL / TRANSDERMALAB12007-05-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076744-002TESTOSTERONE50MG/5GM PACKETGEL / TRANSDERMALAB12007-05-23bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 79 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076744-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A076744-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076744-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076744-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076744-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076744-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076744-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076744-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076744-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076744-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076744-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076744-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076744-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076744-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076744-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076744-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076744-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076744-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076744-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076744-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076744-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A076744-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076744-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076744-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076744-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076744-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076744-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076744-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076744-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A076744-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076744-001AB115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076744-002AB115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076744-001AB115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A076744-002AB115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076744-001AB114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A076744-002AB114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076744-002AB1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076744-001AB11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A076744-002AB11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076744-001AB11782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2124-1GM - Gram63629-2124cdc71355-565e-4d44-bb07-a82ac470daa712021-07-15

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TestosteroneTESTOSTERONEStrides Pharma Science Limitedee54c393-bcfe-4a52-b7b3-1da8750f35d92025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076744
application number: ANDA076744

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2124-16362921240130 PACKET in 1 CARTON (63629-2124-1) > 2.5 g in 1 PACKET (63629-2124-2) 30 packet2021-05-192024-02-28NoNoCurrent