Prescription drug · ANDA
Afatinib NDC 31722-783
Afatinib dimaleate 40 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-783-30 | 31722078330 | 1 BOTTLE in 1 CARTON (31722-783-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 14, 2026 |
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)
- Afatinib
- Generic name (nonproprietary)
- afatinib
- Active ingredients
- Afatinib dimaleate — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210750
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 31722-783_5a8ec67a-afb9-4b6b-e063-6394a90adfc6SPL ID 5a8ec67a-afb9-4b6b-e063-6394a90adfc6SPL set ID ec5b9e00-3eab-4dbd-9bb3-75865b1af485RxCUI 1430446, 1430451, 1430455UNII V1T5K7RZ0BUPC 0331722781305, 0331722783309, 0331722782302
- Pharmacologic class
- Kinase 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
N431722078330followed by a unit qualifier and the quantityPackage 31722-0783-30. 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)
Afatinib tablets are a kinase inhibitor indicated for: • First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test ( 1.1 ) Limitations of Use : Safety and efficacy of afatinib tablets were not established in patients whose tumors have resistant EGFR mutations ( 1.1 ) • Treatment of patients with metastatic, squamous NSCLC progressing after platinum-based chemotherapy ( 1.2 ) 1.1 EGFR Mutation-Positive, Metastatic Non-Small Cell Lung Cancer Afatinib tablets are indicated for the first-line treatment of patients with metastatic non-small cell lung canc…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210750
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.