NDC codes

FDA NDC Directory
Product NDC (as listed)70771-1687Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70771-1687Add 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
70771-1687-370771168703707711687031 KIT in 1 CARTON (70771-1687-3) * 1 VIAL, MULTI-DOSE in 1 CARTON (70771-1686-1) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70771-1765-8)Marketed from Jan 8, 2026

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
Labeler
Zydus Lifesciences LimitedNDC labeler code 70771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215826
Marketing start
Listing expires
Identifiers
Product ID 70771-1687_ebf565fd-e894-45ad-8b0b-8b94bdf375d1SPL ID ebf565fd-e894-45ad-8b0b-8b94bdf375d1SPL set ID 4bae0e2a-dd36-4987-85ee-36a52e642ec7RxCUI 545835, 797544UPC 0370710176815

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.

NDC on a medical claim

N470771168703 followed by a unit qualifier and the quantity

Package 70771-1687-03. 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 70771-1687

What is NDC 70771-1687?
70771-1687 is the product NDC for Leuprolide Acetate kit, listed with the FDA by Zydus Lifesciences Limited. 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?
Zydus Lifesciences Limited, NDC labeler code 70771. 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—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—KitSubcutaneousAmneal Pharmaceuticals LLC70121-253770121-2537-06
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

Other NDCs under ANDA 215826

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

FDA NDC Directory listings under ANDA 215826
ProductStrengthForm · routeLabelerProduct NDC
Leuprolide Acetate—KitZydus Pharmaceuticals USA Inc.70710-1769

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