FDA.reportPublic FDA data

testosterone cypionate

Product NDC
70700-288
Requested package NDC
70700-288-22
11-digit product format
707000288
Labeler code
70700
Product ID
70700-288_3ba43caf-c32b-e5ea-e063-6294a90af950
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
testosterone cypionate
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Xiromed LLC
Application
ANDA215351
Marketing category
ANDA
Marketing start
2023-04-28
Substance
TESTOSTERONE CYPIONATE
Active strength
100 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 43.

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
A215351-001TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-13
A215351-002TESTOSTERONE CYPIONATETESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A215351-001AO
A215351-002AO

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 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-1384e616aacf4f…
2026-09-14 22:38:342026-08A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-1384e616aacf4f…
2026-08-18 06:07:402026-07A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-138072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-136a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-131c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-13ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-13a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-13a72a2bbeb626…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215351-001AO184e616aacf4f…
2026-09-14 22:38:342026-08A215351-002AO184e616aacf4f…
2026-08-18 06:07:402026-07A215351-001AO1caaa826d4ba7…
2026-08-18 06:07:402026-07A215351-002AO1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215351-001AO1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A215351-002AO1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215351-001AO131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215351-002AO131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215351-001AO16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A215351-002AO16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215351-001AO1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215351-002AO1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215351-001AO1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215351-002AO1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215351-001AO103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215351-002AO103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215351-001AO12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215351-002AO12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215351-001AO15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215351-002AO15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215351-001AO1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215351-002AO1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215351-001AO1d06236e962d9…
2024-10-29 15:01 UTC2024-10A215351-002AO1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215351-001AO179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215351-002AO179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215351-001AO1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215351-002AO1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215351-001AO11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215351-002AO11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215351-001AO18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A215351-002AO18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215351-001AO16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215351-002AO16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215351-001AO11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A215351-002AO11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215351-001AO1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A215351-002AO1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215351-001AO1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215351-002AO1a72a2bbeb626…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TESTOSTERONE CYPIONATE100 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
835829Internal RxNorm lookup
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
cab949ca-fde9-c5a9-5561-21e98d86d078Available 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
70700-288-22testosterone cypionate1 in 1 CARTONINJECTION, SOLUTION17
70700-288-22testosterone cypionate10 mL in 1 VIALINJECTION, SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-288-22ML - Milliliter70700-2880daed79a-f76f-4b4e-8411-16dedfb5ba1e12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-288TESTOSTERONE CYPIONATE INJECTION, SOLUTION [XIROMED LLC]4Current NDC, 2 package rows20230430_cab949ca-fde9-c5a9-5561-21e98d86d078.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
testosterone cypionateTESTOSTERONE CYPIONATEA-S Medication Solutions7df45a8d-7d6b-4776-85e3-529527574a4f2026-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215351
application number: ANDA215351
testosterone cypionateTESTOSTERONE CYPIONATENorthStar Rx LLC9ced69c7-cd37-efb6-1bf9-e21c01e56f5b2025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215351
application number: ANDA215351
testosterone cypionateTESTOSTERONE CYPIONATEXiromed LLCcab949ca-fde9-c5a9-5561-21e98d86d0782025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215351
application number: ANDA215351
ndc (package): 70700-288-22
ndc (product): 70700-288
ndc11 (package): 70700028822
testosterone cypionateTESTOSTERONE CYPIONATEA-S Medication Solutionse9d48af3-9514-4dc5-972c-0c1f2547e5c62025-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215351
application number: ANDA215351

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835829testosterone cypionate 100 MG/ML Injectable SolutionPSNcab949ca-fde9-c5a9-5561-21e98d86d0787
2047882testosterone cypionate 200 MG in 1 ML InjectionPSNcab949ca-fde9-c5a9-5561-21e98d86d0787
835840testosterone cypionate 200 MG/ML Injectable SolutionPSNcab949ca-fde9-c5a9-5561-21e98d86d0787
20478821 ML testosterone cypionate 200 MG/ML InjectionSCDcab949ca-fde9-c5a9-5561-21e98d86d0787
835829testosterone cypionate 100 MG/ML Injectable SolutionSCDcab949ca-fde9-c5a9-5561-21e98d86d0787
835840testosterone cypionate 200 MG/ML Injectable SolutionSCDcab949ca-fde9-c5a9-5561-21e98d86d0787
835829testosterone cypionate 1000 MG per 10 ML Injectable SolutionSYcab949ca-fde9-c5a9-5561-21e98d86d0787
2047882testosterone cypionate 200 MG per 1 ML InjectionSYcab949ca-fde9-c5a9-5561-21e98d86d0787

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70700-288-22707000288221 VIAL in 1 CARTON (70700-288-22) / 10 mL in 1 VIAL1 vial2023-04-28NoNoCurrent