FDA.reportPublic FDA data

testosterone cypionate

Product NDC
70700-289
Requested package NDC
70700-289-22
11-digit product format
707000289
Labeler code
70700
Product ID
70700-289_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
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 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A215351-001TESTOSTERONE CYPIONATE100MG/MLINJECTABLE / INJECTIONAO2023-04-13a50c72e98297…
2026-08-01 22:54:322026-06A215351-002TESTOSTERONE CYPIONATE200MG/MLINJECTABLE / INJECTIONAO2023-04-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A215351-001AO1a50c72e98297…
2026-08-01 22:54:322026-06A215351-002AO1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 70700-289-22
ndc (product): 70700-289
ndc11 (package): 70700028922
testosterone cypionateTESTOSTERONE CYPIONATEA-S Medication Solutionse9d48af3-9514-4dc5-972c-0c1f2547e5c62025-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215351
application number: ANDA215351

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 · 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
70700-289-22testosterone cypionate1 in 1 CARTONINJECTION, SOLUTION17
70700-289-22testosterone cypionate1 mL in 1 VIALINJECTION, SOLUTION17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-289-22ML - Milliliter70700-2897f7684b7-80c7-4a15-957b-524f2f1c9a0a12023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-289TESTOSTERONE CYPIONATE INJECTION, SOLUTION [XIROMED LLC]4Current NDC, 2 package rows20230430_cab949ca-fde9-c5a9-5561-21e98d86d078.zip

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
70700-289-22707000289221 VIAL in 1 CARTON (70700-289-22) / 1 mL in 1 VIAL1 vial2023-04-28NoNoCurrent