NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1118Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1118Add 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
71335-1118-1713351118017133511180130 TABLET in 1 BOTTLE (71335-1118-1)Marketed from Feb 25, 2019
71335-1118-2713351118027133511180212 TABLET in 1 BOTTLE (71335-1118-2)Marketed from May 17, 2024
71335-1118-3713351118037133511180320 TABLET in 1 BOTTLE (71335-1118-3)Marketed from May 17, 2024
71335-1118-47133511180471335111804100 TABLET in 1 BOTTLE (71335-1118-4)Marketed from May 17, 2024
71335-1118-5713351118057133511180536 TABLET in 1 BOTTLE (71335-1118-5)Marketed from May 17, 2024
71335-1118-6713351118067133511180624 TABLET in 1 BOTTLE (71335-1118-6)Marketed from May 17, 2024
71335-1118-7713351118077133511180790 TABLET in 1 BOTTLE (71335-1118-7)Marketed from May 17, 2024
71335-1118-871335111808713351118084 TABLET in 1 BOTTLE (71335-1118-8)Marketed from May 17, 2024

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 081235
Marketing start
Listing expires
Other FDA classes
Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers
Product ID 71335-1118_196573c3-e357-4a59-a2bd-2416944fa38aSPL ID 196573c3-e357-4a59-a2bd-2416944fa38aSPL set ID 0b54b5c4-2466-4f85-b9a0-ad93ec4a06a1RxCUI 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

N471335111801 followed by a unit qualifier and the quantity

Package 71335-1118-01. 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 adul…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-1118

What is NDC 71335-1118?
71335-1118 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 081235

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

FDA NDC Directory listings under ANDA 081235
ProductStrengthForm · routeLabelerProduct NDC
MethotrexateMethotrexate sodium 2.5 mg/1TabletOralMylan Pharmaceuticals Inc.0378-0014
MethotrexateMethotrexate sodium 2.5 mg/1TabletOralSafecor Health LLC48433-065
MethotrexateMethotrexate sodium 2.5 mg/1TabletOralMylan Institutional Inc.51079-670
MethotrexateMethotrexate sodium 2.5 mg/1TabletOralGolden State Medical Supply, Inc.51407-121

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in