Home NDC 54288-150 testosterone cypionate
Product NDC 54288-150
11-digit product format 542880150
Labeler code 54288
Product ID 54288-150_5ea88213-31ad-4862-8d67-af84e4f089cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name testosterone cypionate
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR
Labeler BPI Labs LLC
Application ANDA219478
Marketing category ANDA
Marketing start 2026-09-14
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 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219478-001 TESTOSTERONE CYPIONATE TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2026-09-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219478-001 AO
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A219478-001 TESTOSTERONE CYPIONATE 200MG/ML INJECTABLE / INJECTION AO 2026-09-03 84e616aacf4f…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A219478-001 AO 1 84e616aacf4f…
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TESTOSTERONE CYPIONATE 200 mg/mL
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 54288-150-01 54288015001 1 VIAL, MULTI-DOSE in 1 CARTON (54288-150-01) / 10 mL in 1 VIAL, MULTI-DOSE 2026-09-14 No No Current 54288-150-10 54288015010 10 VIAL, MULTI-DOSE in 1 CARTON (54288-150-10) / 10 mL in 1 VIAL, MULTI-DOSE 2026-09-14 No No Current