Prescription drug · ANDA
Pemetrexed NDC 16729-244
Pemetrexed disodium hemipentahydrate 1 g/40mL · Injection, Powder, Lyophilized, For solution · Intravenous · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-244-38 | 16729024438 | 1 VIAL in 1 CARTON (16729-244-38) / 40 mL in 1 VIALMarketed from May 25, 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
- Active ingredients
- Pemetrexed disodium hemipentahydrate — 1 g/40mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Accord Healthcare Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203485
- Marketing start
- Listing expires
- Other FDA classes
- Folic Acid Metabolism Inhibitors (Mechanism)
- Identifiers
- Product ID 16729-244_1d874430-c6ce-cff2-e063-6394a90a4a49SPL ID 1d874430-c6ce-cff2-e063-6394a90a4a49SPL set ID dfd19e67-54cb-c062-e053-2995a90a294aRxCUI 1728072, 1728077, 2601728UNII F4GSH45R4CUPC 0316729229036, 0316729244381, 0316729230117
- 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
N416729024438followed by a unit qualifier and the quantityPackage 16729-0244-38. 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-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 recurrent, meta…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203485
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 |
|---|---|---|---|---|
| Pemetrexed | Pemetrexed disodium hemipentahydrate 100 mg/4mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord Healthcare Inc. | 16729-229 |
| Pemetrexed | Pemetrexed disodium hemipentahydrate 500 mg/20mL | Injection, Powder, Lyophilized, For solutionIntravenous | Accord Healthcare Inc. | 16729-230 |