Testosterone Cypionate

Product NDC
64980-467
11-digit product format
649800467
Labeler code
64980
Product ID
64980-467_bfab9765-fe07-4d6c-97b6-94a454368c75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA207742
Marketing category
ANDA
Marketing start
2018-12-01
Marketing end
0000-00-00
Substance
TESTOSTERONE CYPIONATE
Active strength
200 mg/mL
Pharmacologic classes
Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct64980-467DDiscontinued by firm2026-08-17
excluded packagepackage64980-46764980-467-99DDiscontinued 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 · 34 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64980-467-99DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64980-467-99DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64980-467-99DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64980-467-99DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64980-467-99DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64980-467-99DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64980-467-99DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64980-467-99DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64980-467-99DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64980-467-99DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64980-467-99DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64980-467-99DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64980-467-99IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage64980-467-99IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage64980-467-99IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage64980-467-99IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage64980-467-99IInactivated by FDA8dfbde2a14a4…c9ff85d89658…

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
A207742-001TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207742-001AO

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 06:07:402026-07A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-163f01610625f2…
2019-09-15 20:21 UTC2019-09A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207742-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2017-06-16e64feba35796…

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 06:07:402026-07A207742-001AO1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207742-001AO1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207742-001AO131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207742-001AO16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207742-001AO1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207742-001AO1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207742-001AO103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207742-001AO12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207742-001AO15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207742-001AO1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207742-001AO1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207742-001AO179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207742-001AO1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207742-001AO11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207742-001AO18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207742-001AO15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207742-001AO15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207742-001AO14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207742-001AO174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207742-001AO1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207742-001AO1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207742-001AO187673890dc5c…
2021-03-12 10:30 UTC2021-03A207742-001AO15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207742-001AO18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207742-001AO1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207742-001AO13f01610625f2…
2019-09-15 20:21 UTC2019-09A207742-001AO1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207742-001AO1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207742-001AO16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207742-001AO11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207742-001AO1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207742-001AO1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207742-001AO19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207742-001AO1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207742-001AO13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207742-001AO1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207742-001AO13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207742-001AO13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207742-001AO1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207742-001AO1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-467-99ML - Milliliter64980-467dbb4567f-9cbf-45db-ae97-a7fd87b88af712019-02-13

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
testosterone cypionateTESTOSTERONE CYPIONATEAlvogen Inc.ed65346b-31bc-f872-516d-78d5ab70229e2025-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207742
application number: ANDA207742
testosterone cypionateTESTOSTERONE CYPIONATENuCare Pharmaceuticals, Inc.346604c7-22d0-60c5-e063-6394a90abf0b2025-05-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207742
application number: ANDA207742
testosterone cypionateTESTOSTERONE CYPIONATENuCare Pharmaceuticals,Inc.335ff614-15ec-0792-e063-6294a90a2f082025-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207742
application number: ANDA207742
testosterone cypionateTESTOSTERONE CYPIONATEAsclemed USA, Inc.ffb1ae64-9026-44c9-83a0-32058957ecc92024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207742
application number: ANDA207742