Testopel

Product NDC
43773-1001
11-digit product format
437731001
Labeler code
43773
Product ID
43773-1001_28c87785-4554-4172-9b11-f6a9d72923a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TESTOSTERONE
Dosage form
PELLET
Route
SUBCUTANEOUS
Labeler
Slate Pharma
Application
ANDA080911
Marketing category
ANDA
Marketing start
2009-07-21
Marketing end
0000-00-00
Substance
TESTOSTERONE
Active strength
75 mg/1
Pharmacologic classes
Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
DEA schedule
CIII
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43773-1001IInactivated by FDA2026-08-17
excluded packagepackage43773-100143773-1001-2IInactivated by FDA2026-08-17
excluded packagepackage43773-100143773-1001-3IInactivated by FDA2026-08-17

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 2 · 66 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 packagepackage43773-1001-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43773-1001-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43773-1001-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43773-1001-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43773-1001-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43773-1001-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43773-1001-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43773-1001-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43773-1001-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43773-1001-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43773-1001-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43773-1001-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43773-1001-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43773-1001-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43773-1001-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43773-1001-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43773-1001-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43773-1001-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43773-1001-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43773-1001-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43773-1001-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43773-1001-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43773-1001-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43773-1001-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43773-1001-28af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43773-1001-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43773-1001-2834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43773-1001-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43773-1001-21332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43773-1001-31332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43773-1001-3fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43773-1001-2fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43773-1001-386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43773-1001-286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43773-1001-3bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43773-1001-2bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43773-1001-38dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43773-1001-28dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43773-1001-3e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43773-1001-2e2bbac7714bc…27bdfed8d636…

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
A080911-001TESTOPELTESTOSTERONE75MGPELLET / IMPLANTATIONRS, Approved before 1982

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 06:07:402026-07A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A080911-001TESTOPEL75MGPELLET / IMPLANTATIONRS, Approved before 1982e64feba35796…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43773-1001-22019-11-27C16284748780-19855d018-e846-cd31-e053-dbdaa90ab51aa1741a0b-3d4c-42dc-880d-a06e96cce9ef
43773-1001-32019-11-27C16284748780-19855d018-e846-cd31-e053-dbdaa90ab51aa1741a0b-3d4c-42dc-880d-a06e96cce9ef

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43773-1001-2Testopel1 in 1 AMPULEPELLET12
43773-1001-2Testopel10 in 1 BOXPELLET102
43773-1001-3Testopel1 in 1 AMPULEPELLET12
43773-1001-3Testopel100 in 1 BOXPELLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43773-1001-2EA - Each43773-1001c1ea4802-1918-4e6b-8582-63726dad476312012-07-24
43773-1001-3EA - Each43773-1001521a82dd-a1c9-45d5-86b4-3361fe2a33ba12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TESTOSTERONEACTIVE INGREDIENT3XMK78S47OTESTOPEL (TESTOSTERONE) PELLET [SLATE PHARMA]2
TESTOSTERONEACTIVE MOIETY3XMK78S47OTESTOPEL (TESTOSTERONE) PELLET [SLATE PHARMA]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTESTOPEL (TESTOSTERONE) PELLET [SLATE PHARMA]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTESTOPEL (TESTOSTERONE) PELLET [SLATE PHARMA]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43773-1001TESTOPEL (TESTOSTERONE) PELLET [SLATE PHARMA]2Legacy NDC, 4 package rows20130704_a1741a0b-3d4c-42dc-880d-a06e96cce9ef.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
TestopelTESTOSTERONEEndo USA, Inc.03b9c0b1-5884-11e4-8ed6-0800200c9a662025-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080911
application number: ANDA080911

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404405TESTOPEL 75 MG Subcutaneous Pellet Drug ImplantPSNa1741a0b-3d4c-42dc-880d-a06e96cce9ef2
318240testosterone 75 MG Subcutaneous Pellet Drug ImplantPSNa1741a0b-3d4c-42dc-880d-a06e96cce9ef2
404405testosterone 75 MG Drug Implant [Testopel]SBDa1741a0b-3d4c-42dc-880d-a06e96cce9ef2
318240testosterone 75 MG Drug ImplantSCDa1741a0b-3d4c-42dc-880d-a06e96cce9ef2
404405Testopel 75 MG Drug ImplantSYa1741a0b-3d4c-42dc-880d-a06e96cce9ef2
404405Testopel 75 MG Subcutaneous PelletSYa1741a0b-3d4c-42dc-880d-a06e96cce9ef2
318240testosterone 75 MG Implant PelletSYa1741a0b-3d4c-42dc-880d-a06e96cce9ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43773-1001-2437731001021 in 1 AMPULEHistorical
43773-1001-3437731001031 in 1 AMPULEHistorical