Testosterone Cypionate

Product NDC
69097-802
11-digit product format
690970802
Labeler code
69097
Product ID
69097-802_5a71d184-5faa-444f-8d00-2f2531f342db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Testosterone Cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Cipla USA Inc.
Application
ANDA091244
Marketing category
ANDA
Marketing start
2019-03-26
Substance
TESTOSTERONE CYPIONATE
Active strength
200 mg/mL
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
A091244-001TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091244-001AO

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 06:07:402026-07A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-0187673890dc5c…
2021-03-12 10:30 UTC2021-03A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-013f01610625f2…
2019-09-15 20:21 UTC2019-09A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091244-001TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2012-05-01e64feba35796…

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 06:07:402026-07A091244-001AO1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091244-001AO1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091244-001AO131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091244-001AO16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091244-001AO1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091244-001AO1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091244-001AO103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091244-001AO12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091244-001AO15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091244-001AO1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091244-001AO1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091244-001AO179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091244-001AO1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091244-001AO11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091244-001AO18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091244-001AO15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091244-001AO15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091244-001AO14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091244-001AO174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091244-001AO1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091244-001AO1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091244-001AO187673890dc5c…
2021-03-12 10:30 UTC2021-03A091244-001AO15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091244-001AO18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091244-001AO1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091244-001AO13f01610625f2…
2019-09-15 20:21 UTC2019-09A091244-001AO1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091244-001AO1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091244-001AO16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091244-001AO11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091244-001AO1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091244-001AO1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091244-001AO19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091244-001AO1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091244-001AO13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091244-001AO1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091244-001AO13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091244-001AO13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091244-001AO1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091244-001AO1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE CYPIONATE200 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
M0XW1UBI14Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
835840Internal RxNorm lookup
2047882Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c478Available 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ed2e617f-f28a-1df1-f9fc-c79702f31271Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-802-32Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION15
69097-802-32Testosterone Cypionate1 mL in 1 VIAL, GLASSINJECTION, SOLUTION15
69097-802-37Testosterone Cypionate10 mL in 1 VIAL, GLASSINJECTION, SOLUTION105
69097-802-37Testosterone Cypionate1 in 1 CARTONINJECTION, SOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-802-32ML - Milliliter69097-8022f7f4081-8269-44d8-8718-c16978b992a812019-04-11
69097-802-37ML - Milliliter69097-80289ba2a7f-13bc-49f2-b1ee-f6ec0d7d6a0b12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-802TESTOSTERONE CYPIONATE INJECTION, SOLUTION [CIPLA USA INC.]4Current NDC, Legacy NDC, 4 package rows20250523_b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c478.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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Testosterone CypionateTESTOSTERONE CYPIONATEASCLEMED USA INC.4efcb0be-a19b-4c6b-8a42-cd52a40d095b2026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
Testosterone CypionateTESTOSTERONE CYPIONATEBryant Ranch Prepackad65b1ec-433e-4524-924e-ebad097621262026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
Testosterone CypionateTESTOSTERONE CYPIONATEBryant Ranch Prepack327b4357-6948-4cd6-ad6c-e463ab8600ad2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
Testosterone CypionateTESTOSTERONE CYPIONATEBryant Ranch Prepack1e2f2ed8-7a1c-4d89-aa00-d8a422c8e70b2025-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
Testosterone CypionateTESTOSTERONE CYPIONATECipla USA Inc.b8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4782025-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
ndc (product): 69097-802
Testosterone CypionateTESTOSTERONE CYPIONATEHikma Pharmaceuticals USA Inc.f60c5520-b336-44a2-95d5-f274939fa5952025-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
Testosterone CypionateTESTOSTERONE CYPIONATEHikma Pharmaceuticals USA Inc.5ca67491-4b30-4a47-af0a-be250215d1f02025-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
Testosterone CypionateTESTOSTERONE CYPIONATEA-S Medication Solutions47df0787-af81-43ca-bd67-1b5d127ff3c32024-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
Testosterone CypionateTESTOSTERONE CYPIONATEAsclemed USA, Inc.9d0a1923-be39-41d9-8183-706b227f615c2024-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
Testosterone CypionateTESTOSTERONE CYPIONATEAsclemed USA, Inc.8699c6cb-fede-43ea-ad5e-817700fa7a822024-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
Testosterone CypionateTESTOSTERONE CYPIONATEBryant Ranch Prepack3b0c61de-8cfa-4f76-b07c-0d3b7704b6422023-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
Testosterone CypionateTESTOSTERONE CYPIONATEPadagis US LLCe3e2da65-4b2a-4210-a6ff-cc08c85673812021-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
Testosterone CypionateTESTOSTERONE CYPIONATEProficient Rx LP6bb7d3cc-2b5a-4a48-858e-5421c68b69892019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244
Testosterone CypionateTESTOSTERONE CYPIONATEProficient Rx LP2db0a398-5512-431c-a952-b0290d4fe2d92019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091244
application number: ANDA091244

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047882testosterone cypionate 200 MG in 1 ML InjectionPSNb8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4785
835840testosterone cypionate 200 MG/ML Injectable SolutionPSNb8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4785
20478821 ML testosterone cypionate 200 MG/ML InjectionSCDb8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4785
835840testosterone cypionate 200 MG/ML Injectable SolutionSCDb8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4785
2047882testosterone cypionate 200 MG per 1 ML InjectionSYb8ac5e07-b7e3-4a60-b0d1-8b1f3ad0c4785
2047882testosterone cypionate 200 MG in 1 ML InjectionPSN9d0a1923-be39-41d9-8183-706b227f615c1
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN4bc98c02-6f63-440e-b3ce-89682ade81f61
835840testosterone cypionate 200 MG/ML Injectable SolutionPSN9d0a1923-be39-41d9-8183-706b227f615c1
20478821 ML testosterone cypionate 200 MG/ML InjectionSCD9d0a1923-be39-41d9-8183-706b227f615c1
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD4bc98c02-6f63-440e-b3ce-89682ade81f61
835840testosterone cypionate 200 MG/ML Injectable SolutionSCD9d0a1923-be39-41d9-8183-706b227f615c1
2047882testosterone cypionate 200 MG per 1 ML InjectionSY9d0a1923-be39-41d9-8183-706b227f615c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-802-32690970802321 VIAL, GLASS in 1 CARTON (69097-802-32) / 1 mL in 1 VIAL, GLASS2019-03-260000-00-00NoNoCurrent
69097-802-37690970802371 VIAL, GLASS in 1 CARTON (69097-802-37) / 10 mL in 1 VIAL, GLASS2019-03-260000-00-00NoNoCurrent