What is NDC 0480-4516?

0480-4516 is the product NDC for Pemetrexed, Pemetrexed monohydrate 25 mg/mL solution, concentrate, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Pemetrexed?

57 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pemetrexed NDC 0480-4516 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0480-4516Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00480-4516Add 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 NDC	11-digit (billing)	Package	Copy
0480-4516-01	0048045160100480451601	1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4516-01) / 4 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 1, 2022

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): Pemetrexed
Generic name (nonproprietary): pemetrexed
Active ingredients: Pemetrexed monohydrate — 25 mg/mL
Dosage form: Solution, Concentrate
Route: Intravenous
Labeler: Teva Pharmaceuticals, Inc.NDC labeler code 0480
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208419
Marketing start: Jun 1, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Folic Acid Metabolism Inhibitors (Mechanism)
Identifiers: Product ID 0480-4516_21155bd2-118e-4ce6-adb8-dddc69ae34c7SPL ID 21155bd2-118e-4ce6-adb8-dddc69ae34c7SPL set ID 8b660f68-b770-4e0a-b2f9-25e663deecc3RxCUI 2602363, 2602365, 2602366UNII 236Y2F7D9J
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

N400480451601 followed by a unit qualifier and the quantity

Package 00480-4516-01. 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 Dec 1, 2022.

Indications (excerpt from the label)

Pemetrexed Injection is a folate analog metabolic inhibitor indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. ( 1.1 ) in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. ( 1.1 ) as a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0480-4516

What is NDC 0480-4516?: 0480-4516 is the product NDC for Pemetrexed, Pemetrexed monohydrate 25 mg/mL solution, concentrate, listed with the FDA by Teva Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pemetrexed.
What is the active ingredient?: Pemetrexed monohydrate.
Who is the labeler?: Teva Pharmaceuticals, Inc., NDC labeler code 0480. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pemetrexed?: 57 other product NDCs are listed under this name. See all Pemetrexed 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 Pemetrexed NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pemetrexedpemetrexed disodium	Pemetrexed disodium heptahydrate 100 mg/4mL	Injection, Powder, Lyophilized, For solutionIntravenous	Somerset Therapeutics LLC	70069-834	70069-0834-01
Pemetrexedpemetrexed disodium	Pemetrexed disodium heptahydrate 500 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Somerset Therapeutics LLC	70069-835	70069-0835-01
Pemetrexedpemetrexed disodium	Pemetrexed disodium hemipentahydrate 100 mg/4.2mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-260	25021-0260-10
Pemetrexedpemetrexed disodium	Pemetrexed disodium hemipentahydrate 500 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Sagent Pharmaceuticals	25021-261	25021-0261-50
Pemetrexedpemetrexed disodium	Pemetrexed disodium hemipentahydrate 100 mg/10mL	Injection, Powder, Lyophilized, For solutionIntravenous	NorthStar RxLLC	72603-325	72603-0325-01
Pemetrexedpemetrexed disodium	Pemetrexed disodium hemipentahydrate 500 mg/50mL	Injection, Powder, Lyophilized, For solutionIntravenous	NorthStar RxLLC	72603-425	72603-0425-01
Pemetrexed	Pemetrexed disodium hemipentahydrate 100 mg/1	Injection, Powder, For solutionIntravenous	Solco Healthcare US, LLC	43547-632	43547-0632-01
Pemetrexedpemetrexed disodium	Pemetrexed disodium hemipentahydrate 100 mg/4mL	Injection, Powder, Lyophilized, For solutionIntravenous	Camber Pharmaceuticals, Inc.	31722-336	31722-0336-31
Pemetrexedpemetrexed disodium	Pemetrexed disodium hemipentahydrate 500 mg/20mL	Injection, Powder, Lyophilized, For solutionIntravenous	Camber Pharmaceuticals, Inc.	31722-337	31722-0337-31
Pemetrexedpemetrexed disodium	Pemetrexed disodium hemipentahydrate 100 mg/10mL	InjectionIntravenous	Shilpa Medicare Limited	63759-3048	63759-3048-01

All 58 Pemetrexed NDCs

Other NDCs under NDA 208419

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

FDA NDC Directory listings under NDA 208419
Product	Strength	Form · route	Labeler	Product NDC
Pemetrexed	Pemetrexed monohydrate 25 mg/mL	Solution, ConcentrateIntravenous	Teva Pharmaceuticals, Inc.	0480-4514
Pemetrexed	Pemetrexed monohydrate 25 mg/mL	Solution, ConcentrateIntravenous	Teva Pharmaceuticals, Inc.	0480-4515