Testosterone

Product NDC
0591-2925
11-digit product format
005912925
Labeler code
0591
Product ID
0591-2925_1fffebb2-aabf-4d05-b9c0-5ce61b4cb345
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone
Dosage form
GEL
Route
TRANSDERMAL
Labeler
Actavis Pharma, Inc.
Application
ANDA204570
Marketing category
ANDA
Marketing start
2021-02-12
Marketing end
0000-00-00
Substance
TESTOSTERONE
Active strength
16 mg/g
Pharmacologic classes
Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0591-2925DDiscontinued by firm2026-08-03
excluded packagepackage0591-29250591-2925-30DDiscontinued by firm2026-08-03

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0591-2925-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0591-2925-30f5e01cc5f278…a2eaf40c39c3…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204570-001TESTOSTERONETESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-10
A204570-002TESTOSTERONETESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-17
A204570-003TESTOSTERONETESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A204570-001AB
A204570-002AB2
A204570-003AB2

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 · 109 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204570-002TESTOSTERONE1.62% (20.25MG/1.25GM PACKET)GEL / TRANSDERMALAB22020-07-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204570-003TESTOSTERONE1.62% (40.5MG/2.5GM PACKET)GEL / TRANSDERMALAB22020-07-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204570-001TESTOSTERONE1.62% (20.25MG/1.25GM ACTUATION)GEL, METERED / TRANSDERMALAB2019-04-108072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 109 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204570-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204570-002AB21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204570-003AB21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204570-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204570-002AB2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204570-003AB2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204570-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204570-002AB216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204570-003AB216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204570-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204570-002AB21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204570-003AB21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204570-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204570-002AB21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204570-003AB21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204570-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204570-002AB2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204570-003AB2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204570-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204570-002AB212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204570-003AB212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204570-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204570-002AB215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204570-003AB215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204570-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204570-002AB21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204570-003AB21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204570-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204570-002AB21d06236e962d9…
2024-10-29 15:01 UTC2024-10A204570-003AB21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204570-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204570-002AB2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204570-003AB2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204570-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204570-002AB21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204570-003AB21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204570-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204570-002AB211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204570-003AB211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204570-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2db4fc38-a116-b0ab-3dae-57df54e5f212Product name220250121
386d1b2a-e9b7-0c83-111f-2a77b92895b3Product name520240422
7d55b53c-798b-47ae-992b-3921493a8303Product name120230322
8d753fd6-75b2-4f12-bcbf-339392960afaProduct name120230303
4fbda828-a5be-46fe-83ec-a88da4359919Product name120230104
93cc9bee-8bdc-273d-ec7f-c2c52535317aProduct name720210902
a6389cd1-36d1-4b5c-9934-1139bee93605Product name520210601
f4f0889f-ee8b-471f-9a37-02a035280637Product name120200122
09e1afd3-f431-4380-82c5-438884c25615Product name120190111
a6389cd1-36d1-4b5c-9934-1139bee93605Product name320171212
502efed8-01a5-ef6a-61c6-fe8302b6e26bProduct name220171113
8b700cfd-17dd-41a2-90f5-a80ae8a989a2Product name120171113
9ce0e503-4ae7-2c6a-39ae-85285c29db68Product name220171113
96bdf4b3-71cd-433d-9723-89e50f852992Product name120150810
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-2925-30Testosterone30 in 1 CARTONGEL3011
0591-2925-32Testosterone1.25 g in 1 PACKETGEL1.2511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2925-30GM - Gram0591-292565d6f874-859c-44a0-a51f-4215ea33637212021-03-02
0591-2925-32GM - Gram0591-29252a0b4c6d-4ad8-4ceb-bf23-31ffb851103412021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2925TESTOSTERONE GEL [ACTAVIS PHARMA, INC.]8Legacy NDC, 2 package rows20210213_4f3c2c0a-7dab-4b50-9cae-869c3c2a8498.zip

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
TestosteroneTESTOSTERONEActavis Pharma, Inc.4f3c2c0a-7dab-4b50-9cae-869c3c2a84982025-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204570
application number: ANDA204570
ndc (product): 0591-2925

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATPSN4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
1597120testosterone 1.62 % (20.25MG / 1.25GM) Transdermal GelPSN4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
1597126testosterone 1.62 % (40.5MG / 2.5GM) Transdermal GelPSN4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
15971201250 MG testosterone 0.0162 MG/MG Topical GelSCD4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
15971262500 MG testosterone 0.0162 MG/MG Topical GelSCD4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
159707660 ACTUAT testosterone 20.25 MG/ACTUAT Topical GelSCD4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
1597076testosterone 1.62 % (20.25 MG/ACTUAT) Transdermal Gel Pump, 60 ACTUATSY4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
1597120testosterone 1.62 % Transdermal Gel, 1.25 GMSY4f3c2c0a-7dab-4b50-9cae-869c3c2a849811
1597126testosterone 1.62 % Transdermal Gel, 2.5 GMSY4f3c2c0a-7dab-4b50-9cae-869c3c2a849811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2925-300059129253030 PACKET in 1 CARTON (0591-2925-30) > 1.25 g in 1 PACKET (0591-2925-32) 30 packet2021-02-120000-00-00NoNoCurrent
0591-2925-32005912925321.25 g in 1 PACKET1.25 gHistorical