Prescription drug · ANDA

Testosterone Cypionate NDC 63187-647

Testosterone cypionate 200 mg/mL · Injection · Intramuscular · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-647Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0647Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
63187-647-10631870647106318706471010 mL in 1 VIAL (63187-647-10)Marketed from Dec 1, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Testosterone Cypionate
Generic name (nonproprietary)
testosterone cypionate
Active ingredients
Testosterone cypionate — 200 mg/mL
Dosage form
Injection
Route
Intramuscular
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091244
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers
Product ID 63187-647_a4292cb2-a47f-4e14-a8e0-641c3ae72bacSPL ID a4292cb2-a47f-4e14-a8e0-641c3ae72bacSPL set ID 6bb7d3cc-2b5a-4a48-858e-5421c68b6989RxCUI 835840UNII M0XW1UBI14
Pharmacologic class
Androgen

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N463187064710 followed by a unit qualifier and the quantity

Package 63187-0647-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

INDICATIONS AND USAGE Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) h…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-647

What is NDC 63187-647?
63187-647 is the product NDC for Testosterone Cypionate, Testosterone cypionate 200 mg/mL injection, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Testosterone Cypionate.
What is the active ingredient?
Testosterone cypionate.
Who is the labeler?
Proficient Rx LP, NDC labeler code 63187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Testosterone Cypionate?
53 other product NDCs are listed under this name. See all Testosterone Cypionate NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Testosterone Cypionate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularBPI Labs LLC54288-15054288-0150-0154288-0150-10
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularBPI Labs LLC54288-15654288-0156-01
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularAjenat Pharmaceuticals LLC82983-42482983-0424-01
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularAjenat Pharmaceuticals LLC82983-42582983-0425-01
Testosterone CypionateTestosterone cypionate 200 mg/mLInjectionIntramuscularREMEDYREPACK INC.70518-453870518-4538-00
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularA-S Medication Solutions50090-758450090-7584-00
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularA-S Medication Solutions50090-758550090-7585-00
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularNorthStar Rx LLC72603-28672603-0286-01
Testosterone CypionateTestosterone cypionate 1000 mg/10mLInjection, SolutionIntramuscularEugia US LLC55150-27655150-0276-01
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularEugia US LLC55150-27755150-0277-01

All 54 Testosterone Cypionate NDCs

Other NDCs under ANDA 091244

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 091244
ProductStrengthForm · routeLabelerProduct NDC
Testosterone CypionateTestosterone cypionate 200 mg/mLInjectionIntramuscularHikma Pharmaceuticals USA Inc.0143-9659
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularBryant Ranch Prepack63629-8705
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularBryant Ranch Prepack63629-8706
Testosterone CypionateTestosterone cypionate 200 mg/mLInjectionIntramuscularHikma Pharmaceuticals USA Inc.0143-9005
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularBryant Ranch Prepack72162-1119
Testosterone CypionateTestosterone cypionate 200 mg/mLInjectionIntramuscularHikma Pharmaceuticals USA Inc.0143-9726
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularPadagis US LLC0574-0827
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularASCLEMED USA INC.87063-272
Testosterone CypionateTestosterone cypionate 200 mg/mLInjectionIntramuscularProficient Rx LP71205-289
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularBryant Ranch Prepack71335-2838
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularCipla USA Inc.69097-802
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularA-S Medication Solutions50090-4920
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularAsclemed USA, Inc.76420-741
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularAsclemed USA, Inc.76420-746
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularA-S Medication Solutions50090-8127

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