What is NDC 69097-536?

69097-536 is the product NDC for Testosterone Cypionate, Testosterone cypionate 100 mg/mL injection, listed with the FDA by Cipla USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Testosterone Cypionate NDC 69097-536

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-536Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0536Add 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 NDC	11-digit (billing)	Package	Copy
69097-536-37	6909705363769097053637	10 mL in 1 VIAL, GLASS (69097-536-37)Marketed from Sep 15, 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
Route: Intramuscular
Labeler: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210362
Marketing start: Sep 15, 2023
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Androgen Receptor Agonists (Mechanism)Androstanes (Chemical structure)
Identifiers: Product ID 69097-536_0fb2cc28-39a1-4a94-a01d-23209732dfd7SPL ID 0fb2cc28-39a1-4a94-a01d-23209732dfd7SPL set ID 78d55bad-4a5b-4e21-aeb8-a4c6346208beRxCUI 835829, 835840, 2047882UNII M0XW1UBI14UPC 0369097536374, 0369097537371, 0369097537319
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

N469097053637 followed by a unit qualifier and the quantity

Package 69097-0536-37. 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 May 9, 2025.

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. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or 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") have not been established.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-536

What is NDC 69097-536?: 69097-536 is the product NDC for Testosterone Cypionate, Testosterone cypionate 100 mg/mL injection, listed with the FDA by Cipla USA Inc.. 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?: Cipla USA Inc., NDC labeler code 69097. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
testosterone cypionate	Testosterone cypionate 200 mg/mL	Injection, SolutionIntramuscular	BPI Labs LLC	54288-150	54288-0150-0154288-0150-10
testosterone cypionate	Testosterone cypionate 200 mg/mL	Injection, SolutionIntramuscular	Ajenat Pharmaceuticals LLC	82983-424	82983-0424-01
testosterone cypionate	Testosterone cypionate 200 mg/mL	Injection, SolutionIntramuscular	Ajenat Pharmaceuticals LLC	82983-425	82983-0425-01
testosterone cypionate	Testosterone cypionate 200 mg/mL	Injection, SolutionIntramuscular	BPI Labs LLC	54288-156	54288-0156-01
Testosterone Cypionate	Testosterone cypionate 200 mg/mL	InjectionIntramuscular	REMEDYREPACK INC.	70518-4538	70518-4538-00
testosterone cypionate	Testosterone cypionate 200 mg/mL	Injection, SolutionIntramuscular	A-S Medication Solutions	50090-7585	50090-7585-00
testosterone cypionate	Testosterone cypionate 200 mg/mL	Injection, SolutionIntramuscular	A-S Medication Solutions	50090-7584	50090-7584-00
testosterone cypionate	Testosterone cypionate 200 mg/mL	Injection, SolutionIntramuscular	NorthStar Rx LLC	72603-286	72603-0286-01
Testosterone Cypionate	Testosterone cypionate 1000 mg/10mL	Injection, SolutionIntramuscular	Eugia US LLC	55150-276	55150-0276-01
Testosterone Cypionate	Testosterone cypionate 200 mg/mL	Injection, SolutionIntramuscular	Eugia US LLC	55150-277	55150-0277-01

All 54 Testosterone Cypionate NDCs

Other NDCs under ANDA 210362

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

FDA NDC Directory listings under ANDA 210362
Product	Strength	Form · route	Labeler	Product NDC
Testosterone Cypionate	Testosterone cypionate 200 mg/mL	InjectionIntramuscular	Cipla USA Inc.	69097-537
Testosterone Cypionate	Testosterone cypionate 200 mg/mL	InjectionIntramuscular	REMEDYREPACK INC.	70518-4538