Testosterone Cypionate

Product NDC
50090-4446
11-digit product format
500904446
Labeler code
50090
Product ID
50090-4446_b84533bd-d44d-4dad-94c3-6f6aabd0e66a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
A-S Medication Solutions
Application
ANDA201720
Marketing category
ANDA
Marketing start
2013-06-17
Marketing end
0000-00-00
Substance
TESTOSTERONE CYPIONATE
Active strength
200 mg/mL
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 productproduct50090-4446IInactivated by FDA2026-08-17
excluded packagepackage50090-444650090-4446-0IInactivated 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 1 · 30 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 packagepackage50090-4446-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4446-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4446-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4446-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4446-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4446-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4446-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4446-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4446-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4446-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4446-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4446-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4446-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4446-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4446-01332a3947898…d4bfe170f9cd…

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
A201720-001TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTION2013-06-03
A201720-002TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTION2013-06-03

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 06:07:402026-07A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTION2013-06-03caaa826d4ba7…
2026-08-18 06:07:402026-07A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTION2013-06-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTION2013-06-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTION2013-06-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTION2013-06-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTION2013-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTION2013-06-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTION2013-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTION2013-06-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTION2013-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTION2013-06-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTION2013-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTION2013-06-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTION2013-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTION2013-06-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTION2013-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2013-06-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2013-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTION2013-06-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTION2013-06-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2013-06-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2013-06-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2013-06-0379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2013-06-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2013-06-03301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2013-06-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2013-06-031e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2013-06-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2013-06-038072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2013-06-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2013-06-035c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2013-06-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2013-06-035d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2013-06-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2013-06-034b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2013-06-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2013-06-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2013-06-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201720-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2013-06-03bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201720-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2013-06-03bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201720-001AO15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201720-002AO15bbf6a4d5a75…
2024-10-29 15:01 UTC2024-10A201720-001AO1d06236e962d9…
2024-10-29 15:01 UTC2024-10A201720-002AO1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201720-001AO179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201720-002AO179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201720-001AO1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201720-002AO1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201720-001AO11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201720-002AO11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201720-001AO18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201720-002AO18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201720-001AO15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201720-002AO15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201720-001AO15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A201720-002AO15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201720-001AO14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A201720-002AO14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201720-001AO174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A201720-002AO174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201720-001AO1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A201720-002AO1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201720-001AO1782e0a99824c…
2021-12-28 21:50 UTC2021-12A201720-002AO1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201720-001AO187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201720-002AO187673890dc5c…
2021-03-12 10:30 UTC2021-03A201720-001AO15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A201720-002AO15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201720-001AO18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A201720-002AO18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201720-001AO1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A201720-002AO1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201720-001AO13f01610625f2…
2019-12-14 00:12 UTC2019-12A201720-002AO13f01610625f2…
2019-09-15 20:21 UTC2019-09A201720-001AO1b00525d2431f…
2019-09-15 20:21 UTC2019-09A201720-002AO1b00525d2431f…
2019-07-19 19:46 UTC2019-07A201720-001AO1ea99ee380514…
2019-07-19 19:46 UTC2019-07A201720-002AO1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201720-001AO16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201720-002AO16a51e52b5d6a…

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4446-02023-01-30C16284748780-1f386c649-b1a4-0266-e053-dadaa90a7c1aTestosterone Cypionate Injection C-III

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4446-0Testosterone Cypionate10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION104
50090-4446-0Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4446TESTOSTERONE CYPIONATE INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20210418_3602f307-19c3-4f09-a3e3-98c10a19ec28.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
Testosterone CypionateTESTOSTERONE CYPIONATESun Pharmaceutical Industries, Inc.3653a602-4551-4e6c-84a7-31861f5dc4822025-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201720
application number: ANDA201720

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN3602f307-19c3-4f09-a3e3-98c10a19ec284
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD3602f307-19c3-4f09-a3e3-98c10a19ec284

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4446-0500904446001 VIAL, MULTI-DOSE in 1 CARTON (50090-4446-0) > 10 mL in 1 VIAL, MULTI-DOSE2019-08-020000-00-00NoNoCurrent