NDC codes

FDA NDC Directory
Product NDC (as listed)72843-591Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72843-0591Add 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
72843-591-9972843059199728430591991 KIT in 1 CARTON (72843-591-99) * 1 VIAL, MULTI-DOSE in 1 CARTON (72843-590-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKETMarketed from Oct 25, 2024

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)
leuprolide acetate
Generic name (nonproprietary)
leuprolide acetate
Dosage form
Kit
Route
Subcutaneous
Labeler
UBI Pharma Inc.NDC labeler code 72843
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217957
Marketing start
Listing expires
Identifiers
Product ID 72843-591_4e3665c7-c296-c3d1-e063-6294a90ada86SPL ID 4e3665c7-c296-c3d1-e063-6294a90ada86SPL set ID cd46628f-055f-4da9-8c38-fa69af34eb4dRxCUI 545835, 797544UPC 0072843590017

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

N472843059199 followed by a unit qualifier and the quantity

Package 72843-0591-99. 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 72843-591

What is NDC 72843-591?
72843-591 is the product NDC for leuprolide acetate kit, listed with the FDA by UBI Pharma Inc.. 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?
UBI Pharma Inc., NDC labeler code 72843. 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—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 217957

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

FDA NDC Directory listings under ANDA 217957
ProductStrengthForm · routeLabelerProduct NDC
leuprolide acetate—KitSubcutaneousPAI Holdings, LLC dba PAI Pharma0121-2106

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