Prescription drug · ANDA
Erlotinib (Erlotinib hydrochloride) NDC 72485-218
Erlotinib hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Armas Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72485-218-30 | 7248502183072485021830 | 1 BOTTLE in 1 BOX (72485-218-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from Nov 6, 2019 |
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 hydrochloride
- Active ingredients
- Erlotinib hydrochloride — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Armas Pharmaceuticals Inc.NDC labeler code 72485
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211960
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 72485-218_bc4532f4-6a0a-4fd1-a630-8b524c02c7aaSPL ID bc4532f4-6a0a-4fd1-a630-8b524c02c7aaSPL set ID 2c4c7353-b81c-4651-8aac-6d15e88145afRxCUI 603203UNII DA87705X9KUPC 0372485218301
- 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
N472485021830followed by a unit qualifier and the quantityPackage 72485-0218-30. 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 tablet is 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, unrespectable 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 tumors hav…
Excerpt only. Read the full label for complete information.
About NDC 72485-218
- What is NDC 72485-218?
- 72485-218 is the product NDC for Erlotinib (erlotinib hydrochloride), Erlotinib hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Armas Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Erlotinib (Erlotinib hydrochloride).
- What is the active ingredient?
- Erlotinib hydrochloride.
- Who is the labeler?
- Armas Pharmaceuticals Inc., NDC labeler code 72485. 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 100 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-531 | 59651-0531-0359651-0531-10 |
| 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 |
Other NDCs under ANDA 211960
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 |
|---|---|---|---|---|
| Erlotiniberlotinib hydrochloride | Erlotinib hydrochloride 25 mg/1 | Tablet, Film coatedOral | Armas Pharmaceuticals Inc. | 72485-217 |
| Erlotiniberlotinib hydrochloride | Erlotinib hydrochloride 150 mg/1 | Tablet, Film coatedOral | Armas Pharmaceuticals Inc. | 72485-219 |