NDC codes

FDA NDC Directory
Product NDC (as listed)70121-2537Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70121-2537Add 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
70121-2537-670121253706701212537061 KIT in 1 CARTON (70121-2537-6) * 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1695-2) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70121-2538-9)Marketed from Nov 7, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
leuprolide acetate
Generic name (nonproprietary)
leuprolide acetate
Dosage form
Kit
Route
Subcutaneous
Labeler
Amneal Pharmaceuticals LLCNDC labeler code 70121
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215336
Marketing start
Listing expires
Identifiers
Product ID 70121-2537_7a52db30-cd48-454c-8fab-6ba14c8e7599SPL ID 7a52db30-cd48-454c-8fab-6ba14c8e7599SPL set ID 4838c674-044e-46b2-81e7-c691b99d8fa5RxCUI 545835, 797544

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

N470121253706 followed by a unit qualifier and the quantity

Package 70121-2537-06. 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 Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70121-2537

What is NDC 70121-2537?
70121-2537 is the product NDC for leuprolide acetate kit, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
leuprolide acetate.
Who is the labeler?
Amneal Pharmaceuticals LLC, NDC labeler code 70121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for leuprolide acetate?
11 other product NDCs are listed under this name. See all leuprolide acetate 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 leuprolide acetate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Leuprolide AcetateLeuprolide acetate 1 mg/.2mLInjectionSubcutaneousEndo USA, Inc.42023-25942023-0259-00
Leuprolide Acetate—KitZydus Pharmaceuticals USA Inc.70710-176970710-1769-03
Leuprolide Acetate—KitZydus Lifesciences Limited70771-168770771-1687-03
leuprolide acetate—KitSubcutaneousPAI Holdings, LLC dba PAI Pharma0121-210600121-2106-02
leuprolide acetate—KitSubcutaneousUBI Pharma Inc.72843-59172843-0591-99
Leuprolide Acetate—KitSubcutaneousMeitheal Pharmaceuticals Inc71288-56971288-0569-90
Leuprolide Acetate—KitSubcutaneousNorthStar RxLLC72603-34472603-0344-01
Leuprolide Acetate—KitEugia US LLC55150-47855150-0478-01
Leuprolide Acetate—KitVGYAAN Pharmaceuticals LLC72664-61172664-0611-28
leuprolide acetate—KitSun Pharmaceutical Industries, Inc.47335-93647335-0936-40

All 12 leuprolide acetate NDCs

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