Prescription drug · ANDA
Erlotinib Hydrochloride NDC 46708-566
Erlotinib hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-566-30 | 46708056630 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-566-30)Marketed from Jul 9, 2021 | |
| 46708-566-90 | 46708056690 | 90 TABLET, FILM COATED in 1 BOTTLE (46708-566-90)Marketed from Jul 9, 2021 |
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)
- Erlotinib Hydrochloride
- Generic name (nonproprietary)
- erlotinib hydrochloride
- Active ingredients
- Erlotinib hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214719
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-566_966e67f7-6259-4b1c-8c6a-b2589d57e1edSPL ID 966e67f7-6259-4b1c-8c6a-b2589d57e1edSPL set ID ab6f3cb3-34a8-4492-a5d7-fb6b055a2d6bRxCUI 603203, 603206, 603208UNII DA87705X9KUPC 0346708567309, 0346708566302, 0346708565305
- 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
N446708056630followed by a unit qualifier and the quantityPackage 46708-0566-30. 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)
Erlotinib tablets are a kinase inhibitor indicated for: The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. (1.1) First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. (1.2) Limitations of Use: Safety and efficacy of erlotinib tablets has not been established in patients with NSCLC whose tumors have…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214719
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 |
|---|---|---|---|---|
| Erlotinib Hydrochloride | Erlotinib hydrochloride 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-566 |
| Erlotinib Hydrochloride | Erlotinib hydrochloride 25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-565 |
| Erlotinib Hydrochloride | Erlotinib hydrochloride 150 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-567 |
| Erlotinib Hydrochloride | Erlotinib hydrochloride 25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-565 |
| Erlotinib Hydrochloride | Erlotinib hydrochloride 150 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-567 |