NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2221Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2221Add 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
71335-2221-1713352221017133522210130 TABLET in 1 BOTTLE (71335-2221-1)Marketed from Aug 15, 2023
71335-2221-2713352221027133522210212 TABLET in 1 BOTTLE (71335-2221-2)Marketed from Aug 15, 2023
71335-2221-3713352221037133522210320 TABLET in 1 BOTTLE (71335-2221-3)Marketed from Aug 15, 2023
71335-2221-47133522210471335222104100 TABLET in 1 BOTTLE (71335-2221-4)Marketed from Aug 15, 2023
71335-2221-5713352221057133522210536 TABLET in 1 BOTTLE (71335-2221-5)Marketed from Aug 15, 2023
71335-2221-6713352221067133522210624 TABLET in 1 BOTTLE (71335-2221-6)Marketed from Aug 15, 2023
71335-2221-7713352221077133522210790 TABLET in 1 BOTTLE (71335-2221-7)Marketed from Aug 15, 2023
71335-2221-871335222108713352221084 TABLET in 1 BOTTLE (71335-2221-8)Marketed from Aug 15, 2023

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)
Methotrexate
Generic name (nonproprietary)
methotrexate
Active ingredients
Methotrexate sodium — 2.5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210454
Marketing start
Listing expires
Other FDA classes
Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers
Product ID 71335-2221_5c146783-d4cc-4700-87b9-1fd872af6913SPL ID 5c146783-d4cc-4700-87b9-1fd872af6913SPL set ID b6e61c50-024a-494f-b04c-100fb371a837RxCUI 105585UNII 3IG1E710ZN
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N471335222101 followed by a unit qualifier and the quantity

Package 71335-2221-01. 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)

Methotrexate tablets are a dihydrofolate reductase inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen ( 1.1 ) Treatment of adults with mycosis fungoides ( 1.1 ) Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen ( 1.1 ) Treatment of adults with rheumatoid arthritis ( 1.2 ) Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) ( 1.3 ) Treatment of adults with severe psoriasis ( 1.4 ) 1.1 Neoplastic Diseases Methotrexate tablets are indicated for the: treatment of adults and pediatr…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2221

What is NDC 71335-2221?
71335-2221 is the product NDC for Methotrexate, Methotrexate sodium 2.5 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 8 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Methotrexate.
What is the active ingredient?
Methotrexate sodium.
Who is the labeler?
Bryant Ranch Prepack, NDC labeler code 71335. 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 210454

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

FDA NDC Directory listings under ANDA 210454
ProductStrengthForm · routeLabelerProduct NDC
MethotrexateMethotrexate sodium 2.5 mg/1TabletOralAurobindo Pharma Limited59651-182
MethotrexateMethotrexate sodium 2.5 mg/1TabletOralChartwell RX, LLC62135-772
MethotrexateMethotrexate sodium 2.5 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3765

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