Prescription drug · ANDA
Erlotinib NDC 59651-531
Erlotinib hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-531-03 | 5965105310359651053103 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-531-03)Marketed from Jun 22, 2022 | |
| 59651-531-10 | 5965105311059651053110 | 1 BLISTER PACK in 1 CARTON (59651-531-10) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jun 22, 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)
- Erlotinib
- Generic name (nonproprietary)
- erlotinib
- Active ingredients
- Erlotinib hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216342
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 59651-531_3ecafc1e-979a-4aff-a276-18fc0b110491SPL ID 3ecafc1e-979a-4aff-a276-18fc0b110491SPL set ID 3ecafc1e-979a-4aff-a276-18fc0b110491RxCUI 603203, 603206, 603208UNII DA87705X9K
- 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
N459651053103followed by a unit qualifier and the quantityPackage 59651-0531-03. 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 have not been established in patients with NSCLC whose tumor…
Excerpt only. Read the full label for complete information.
About NDC 59651-531
- What is NDC 59651-531?
- 59651-531 is the product NDC for Erlotinib, Erlotinib hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Erlotinib.
- What is the active ingredient?
- Erlotinib hydrochloride.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Erlotinib?
- 20 other product NDCs are listed under this name. See all Erlotinib NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Erlotinib products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Erlotinib | Erlotinib hydrochloride 25 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-263 | 31722-0263-30 |
| Erlotinib | Erlotinib hydrochloride 100 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-264 | 31722-0264-30 |
| Erlotinib | Erlotinib hydrochloride 150 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-265 | 31722-0265-30 |
| Erlotinib | Erlotinib hydrochloride 25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-530 | 59651-0530-0359651-0530-10 |
| Erlotinib | Erlotinib hydrochloride 150 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-532 | 59651-0532-0359651-0532-10 |
| Erlotinib | Erlotinib hydrochloride 25 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7662 | 00093-7662-56 |
| Erlotinib | Erlotinib hydrochloride 25 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-913 | 68382-0913-0668382-0913-1668382-0913-84 |
| Erlotinib | Erlotinib hydrochloride 100 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-914 | 68382-0914-0668382-0914-1668382-0914-84 |
| Erlotinib | Erlotinib hydrochloride 150 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-915 | 68382-0915-0668382-0915-1668382-0915-84 |
| Erlotinib | Erlotinib hydrochloride 25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1521 | 70771-1521-0370771-1521-0770771-1521-09 |
Other NDCs under ANDA 216342
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 | Erlotinib hydrochloride 25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-530 |
| Erlotinib | Erlotinib hydrochloride 150 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-532 |