Prescription drug · ANDA
Pemetrexed (Pemetrexed disodium) NDC 71288-146
Pemetrexed disodium heptahydrate 500 mg/20mL · Injection, Powder, Lyophilized, For solution · Intravenous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-146-50 | 7128801465071288014650 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-146-50) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 13, 2022 |
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)
- Pemetrexed
- Generic name (nonproprietary)
- pemetrexed disodium
- Active ingredients
- Pemetrexed disodium heptahydrate — 500 mg/20mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Meitheal Pharmaceuticals Inc.NDC labeler code 71288
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215479
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 71288-146_b369ac27-0118-4e53-be05-c9ba2dbf6875SPL ID b369ac27-0118-4e53-be05-c9ba2dbf6875SPL set ID b185f459-5489-4e18-8521-1686b5d16f67RxCUI 1728072, 1728077, 2601728, 2602136UNII 9T47E4OM16
- 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.
- NDC on a medical claim
N471288014650followed by a unit qualifier and the quantityPackage 71288-0146-50. 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)
Pemetrexed for 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 EGFR or 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. ( 1.1 ) as a single agent for the treatment of patients with re…
Excerpt only. Read the full label for complete information.
About NDC 71288-146
- What is NDC 71288-146?
- 71288-146 is the product NDC for Pemetrexed (pemetrexed disodium), Pemetrexed disodium heptahydrate 500 mg/20mL injection, powder, lyophilized, for solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pemetrexed (Pemetrexed disodium).
- What is the active ingredient?
- Pemetrexed disodium heptahydrate.
- Who is the labeler?
- Meitheal Pharmaceuticals Inc., NDC labeler code 71288. 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.
Related NDCs: other Pemetrexed products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 215479
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Pemetrexedpemetrexed disodium | Pemetrexed disodium heptahydrate 100 mg/4.2mL | Injection, Powder, Lyophilized, For solutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-145 |
| Pemetrexedpemetrexed disodium | Pemetrexed disodium heptahydrate 750 mg/30mL | Injection, Powder, Lyophilized, For solutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-147 |
| Pemetrexedpemetrexed disodium | Pemetrexed disodium heptahydrate 1 g/40mL | Injection, Powder, Lyophilized, For solutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-148 |