NDC codes

FDA NDC Directory
Product NDC (as listed)0143-9367Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00143-9367Add 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
0143-9367-0100143936701001439367011 VIAL in 1 BOX (0143-9367-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIALMarketed from Sep 6, 2005

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Methotrexate
Generic name (nonproprietary)
methotrexate
Active ingredients
Methotrexate — 1 g/1
Dosage form
Injection, Powder, Lyophilized, For solution
Route
Intra-arterial, Intramuscular, Intrathecal, Intravenous
Labeler
Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 040632
Marketing start
Listing expires
Other FDA classes
Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers
Product ID 0143-9367_7950579c-084b-472b-a7ce-f342691aff97SPL ID 7950579c-084b-472b-a7ce-f342691aff97SPL set ID 8593f7fc-eabe-44ae-bb05-b3d7d408e4f7RxCUI 311625UNII YL5FZ2Y5U1
Pharmacologic class
Folate Analog Metabolic Inhibitor

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

N400143936701 followed by a unit qualifier and the quantity

Package 00143-9367-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Neoplastic Diseases Methotrexate is indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole. In acute lymphocytic leukemia, methotrexate is indicated in the prophylaxis of meningeal leukemia and is used in maintenance therapy in combination with other chemotherapeutic agents. Methotrexate is also indicated in the treatment of meningeal leukemia. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T cell lymphoma), and lung cancer, particularly squamous cell and small cell types. Methotrex…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9367

What is NDC 0143-9367?
0143-9367 is the product NDC for Methotrexate, Methotrexate 1 g/1 injection, powder, lyophilized, for solution, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Methotrexate.
What is the active ingredient?
Methotrexate.
Who is the labeler?
Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Methotrexate?
51 other product NDCs are listed under this name. See all Methotrexate 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 Methotrexate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MethotrexateMethotrexate 2.5 mg/1TabletOralAmerican Health Packaging60687-97560687-0975-94
MethotrexateMethotrexate sodium 25 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousAlembic Pharmaceuticals Limited46708-71146708-0711-05
MethotrexateMethotrexate sodium 25 mg/mLInjection, SolutionIntramuscular, Intrathecal, Intravenous, SubcutaneousAlembic Pharmaceuticals Limited46708-71246708-0712-01
MethotrexateMethotrexate sodium 25 mg/mLInjection, SolutionIntramuscular, Intravenous, SubcutaneousAlembic Pharmaceuticals Inc.62332-71162332-0711-05
MethotrexateMethotrexate sodium 25 mg/mLInjection, SolutionIntramuscular, Intrathecal, Intravenous, SubcutaneousAlembic Pharmaceuticals Inc.62332-71262332-0712-01
MethotrexateMethotrexate 2.5 mg/1TabletOralAvPAK50268-55450268-0554-15
MethotrexateMethotrexate sodium 2.5 mg/1TabletOralSafecor Health LLC48433-06548433-0065-05
MethotrexateMethotrexate sodium 2.5 mg/1TabletOralCoupler LLC67046-152467046-1524-03
MethotrexateMethotrexate sodium 25 mg/mLInjection, SolutionIntramuscular, Intrathecal, Intravenous, SubcutaneousHospira, Inc.61703-16161703-0161-05
MethotrexateMethotrexate sodium 50 mg/2mLInjection, SolutionIntramuscular, Intrathecal, Intravenous, SubcutaneousEugia US LLC55150-51055150-0510-0155150-0510-05

All 52 Methotrexate NDCs

Other NDCs under ANDA 040632

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

FDA NDC Directory listings under ANDA 040632
ProductStrengthForm · routeLabelerProduct NDC
MethotrexateMethotrexate 1 g/1Injection, Powder, Lyophilized, For solutionIntra-arterial, Intramuscular, Intrathecal, IntravenousHikma Pharmaceuticals USA Inc.0143-9830

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