NDC codes

FDA NDC Directory
Product NDC (as listed)0009-0086Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00009-0086Add 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
0009-0086-01000090086011 VIAL in 1 CARTON (0009-0086-01) / 1 mL in 1 VIALMarketed from Jul 1, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Depo-Testosterone
Generic name (nonproprietary)
testosterone cypionate
Active ingredients
Testosterone cypionate — 200 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 085635
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers
Product ID 0009-0086_d47c9c86-9b65-4daa-b5dd-63975d19e154SPL ID d47c9c86-9b65-4daa-b5dd-63975d19e154SPL set ID 735b5bf3-4464-412c-a072-1bd02f2e5380RxCUI 835829, 835831, 835840, 835842UNII 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

N400009008601 followed by a unit qualifier and the quantity

Package 00009-0086-01. 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 DEPO-Testosterone Injection 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 LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of DEPO-Testosterone (testosterone cypionate) in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 085635

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

FDA NDC Directory listings under ANDA 085635
ProductStrengthForm · routeLabelerProduct NDC
Depo-Testosteronetestosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularPharmacia & Upjohn Company LLC0009-0417
Depo-Testosteronetestosterone cypionateTestosterone cypionate 100 mg/mLInjection, SolutionIntramuscularPharmacia & Upjohn Company LLC0009-0347
Depo-Testosteronetestosterone cypionateTestosterone cypionate 100 mg/mLInjection, SolutionIntramuscularPharmacia & Upjohn Company LLC0009-0085
Testosterone CypionateTestosterone cypionate 100 mg/mLInjection, SolutionIntramuscularHospira, Inc.0409-6557
Testosterone CypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularHospira, Inc.0409-6562
Depo-Testosteronetestosterone cypionateTestosterone cypionate 100 mg/mLInjection, SolutionIntramuscularAsclemed USA, Inc.76420-425

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