testosterone

Product NDC
45802-610
11-digit product format
458020610
Labeler code
45802
Product ID
45802-610_49fac6b0-d016-4de8-a375-64de3e07aaa0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA204255
Marketing category
ANDA
Marketing start
2017-06-28
Substance
TESTOSTERONE
Active strength
30 mg/1.5mL
Pharmacologic classes
Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204255-001TESTOSTERONETESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204255-001AT

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-283f01610625f2…
2019-09-15 20:21 UTC2019-09A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204255-001TESTOSTERONE30MG/1.5ML ACTUATIONSOLUTION, METERED / TRANSDERMALATRS2017-02-28e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204255-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204255-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204255-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204255-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204255-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204255-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204255-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204255-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204255-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204255-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204255-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204255-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204255-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204255-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204255-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204255-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204255-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204255-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204255-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204255-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204255-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204255-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A204255-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204255-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204255-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204255-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A204255-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204255-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204255-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204255-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204255-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204255-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204255-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204255-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204255-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204255-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204255-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204255-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204255-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204255-001AT1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
testosterone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE30 mg/1.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3XMK78S47OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1599949Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c0c56607-e995-4bed-9c62-e33a722b38b5Available on FDA.report

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
45802-610-01testosterone110 mL in 1 BOTTLE, PUMPSOLUTION11010
45802-610-01testosterone1 in 1 CARTONSOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-610-01ML - Milliliter45802-610f3422015-30be-461b-9871-774547db876112017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-610TESTOSTERONE SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]9Current NDC, Legacy NDC, 2 package rows20230316_c0c56607-e995-4bed-9c62-e33a722b38b5.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
testosteroneTESTOSTERONEPadagis Israel Pharmaceuticals Ltdc0c56607-e995-4bed-9c62-e33a722b38b52025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204255
application number: ANDA204255
ndc (product): 45802-610
testosteroneTESTOSTERONEBryant Ranch Prepack5be74193-de73-436d-a9a1-35a857bc8e0c2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204255
application number: ANDA204255
testosteroneTESTOSTERONEBryant Ranch Prepackd22a072f-529b-4878-90fc-4365d9dc67e62024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204255
application number: ANDA204255

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATPSNd22a072f-529b-4878-90fc-4365d9dc67e6106
159994960 ACTUAT testosterone 30 MG/ACTUAT Topical SolutionSCDd22a072f-529b-4878-90fc-4365d9dc67e6106
159994960 ACTUAT testosterone 30 MG/1.5 ML ACTUAT Topical SolutionSYd22a072f-529b-4878-90fc-4365d9dc67e6106
1599949testosterone (as testosterone propionate) 2 % Topical SolutionSYd22a072f-529b-4878-90fc-4365d9dc67e6106
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATSYd22a072f-529b-4878-90fc-4365d9dc67e6106
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATPSN5be74193-de73-436d-a9a1-35a857bc8e0c105
159994960 ACTUAT testosterone 30 MG/ACTUAT Topical SolutionSCD5be74193-de73-436d-a9a1-35a857bc8e0c105
159994960 ACTUAT testosterone 30 MG/1.5 ML ACTUAT Topical SolutionSY5be74193-de73-436d-a9a1-35a857bc8e0c105
1599949testosterone (as testosterone propionate) 2 % Topical SolutionSY5be74193-de73-436d-a9a1-35a857bc8e0c105
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATSY5be74193-de73-436d-a9a1-35a857bc8e0c105
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATPSNc0c56607-e995-4bed-9c62-e33a722b38b510
159994960 ACTUAT testosterone 30 MG/ACTUAT Topical SolutionSCDc0c56607-e995-4bed-9c62-e33a722b38b510
159994960 ACTUAT testosterone 30 MG/1.5 ML ACTUAT Topical SolutionSYc0c56607-e995-4bed-9c62-e33a722b38b510
1599949testosterone (as testosterone propionate) 2 % Topical SolutionSYc0c56607-e995-4bed-9c62-e33a722b38b510
1599949testosterone 2 % (30 MG/ACTUAT) Topical Solution, 60 ACTUATSYc0c56607-e995-4bed-9c62-e33a722b38b510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45802-610-01458020610011 BOTTLE, PUMP in 1 CARTON (45802-610-01) / 110 mL in 1 BOTTLE, PUMP2017-06-280000-00-00NoNoCurrent