NDC codes

FDA NDC Directory
Product NDC (as listed)70700-288Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70700-0288Add 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
70700-288-2270700028822707000288221 VIAL in 1 CARTON (70700-288-22) / 10 mL in 1 VIALMarketed from Apr 28, 2023

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 — 100 mg/mL
Dosage form
Injection, Solution
Route
Intramuscular
Labeler
Xiromed LLCNDC labeler code 70700
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215351
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers
Product ID 70700-288_3ba43caf-c32b-e5ea-e063-6294a90af950SPL ID 3ba43caf-c32b-e5ea-e063-6294a90af950SPL set ID cab949ca-fde9-c5a9-5561-21e98d86d078RxCUI 835829, 835840, 2047882UNII M0XW1UBI14UPC 0370700289228, 0370700290224, 0370700288221
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

N470700028822 followed by a unit qualifier and the quantity

Package 70700-0288-22. 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 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 Testosterone Cypionate Injection 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)

About NDC 70700-288

What is NDC 70700-288?
70700-288 is the product NDC for testosterone cypionate, Testosterone cypionate 100 mg/mL injection, solution, listed with the FDA by Xiromed LLC. 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?
Xiromed LLC, NDC labeler code 70700. 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, SolutionIntramuscularAjenat Pharmaceuticals LLC82983-42482983-0424-01
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularAjenat Pharmaceuticals LLC82983-42582983-0425-01
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularBPI Labs LLC54288-15654288-0156-01
Testosterone CypionateTestosterone cypionate 200 mg/mLInjectionIntramuscularREMEDYREPACK INC.70518-453870518-4538-00
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularA-S Medication Solutions50090-758550090-7585-00
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularA-S Medication Solutions50090-758450090-7584-00
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 215351

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

FDA NDC Directory listings under ANDA 215351
ProductStrengthForm · routeLabelerProduct NDC
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularA-S Medication Solutions50090-7584
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularA-S Medication Solutions50090-7585
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularXiromed LLC70700-289
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularXiromed LLC70700-290
testosterone cypionateTestosterone cypionate 200 mg/mLInjection, SolutionIntramuscularNorthStar Rx LLC72603-286

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