Prescription drug · ANDA
Erlotinib Hydrochloride NDC 72205-081
Erlotinib hydrochloride 100 mg/1 · Tablet, Film coated · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-081-30 | 7220500813072205008130 | 1 BOTTLE in 1 CARTON (72205-081-30) / 30 TABLET, FILM COATED in 1 BOTTLEMarketed from May 11, 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
- Labeler
- Novadoz Pharmaceuticals LLCNDC labeler code 72205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214366
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 72205-081_4cff04f5-3693-4d87-a9f8-a2b195e3d26eSPL ID 4cff04f5-3693-4d87-a9f8-a2b195e3d26eSPL set ID 4cff04f5-3693-4d87-a9f8-a2b195e3d26eRxCUI 603203, 603206, 603208UNII DA87705X9KUPC 0372205081307, 0372205082304, 0372205080300
- 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
N472205008130followed by a unit qualifier and the quantityPackage 72205-0081-30. 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, 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 tumors h…
Excerpt only. Read the full label for complete information.
About NDC 72205-081
- What is NDC 72205-081?
- 72205-081 is the product NDC for Erlotinib Hydrochloride, Erlotinib hydrochloride 100 mg/1 tablet, film coated, listed with the FDA by Novadoz Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Erlotinib Hydrochloride.
- What is the active ingredient?
- Erlotinib hydrochloride.
- Who is the labeler?
- Novadoz Pharmaceuticals LLC, NDC labeler code 72205. 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 Hydrochloride?
- 8 other product NDCs are listed under this name. See all Erlotinib Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Erlotinib Hydrochloride 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 Hydrochloride | Erlotinib hydrochloride 25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-565 | 46708-0565-3046708-0565-90 |
| Erlotinib Hydrochloride | Erlotinib hydrochloride 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-566 | 46708-0566-3046708-0566-90 |
| Erlotinib Hydrochloride | Erlotinib hydrochloride 150 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-567 | 46708-0567-3046708-0567-90 |
| Erlotinib Hydrochloride | Erlotinib hydrochloride 25 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-565 | 62332-0565-3062332-0565-90 |
| Erlotinib Hydrochloride | Erlotinib hydrochloride 100 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-566 | 62332-0566-3062332-0566-90 |
| Erlotinib Hydrochloride | Erlotinib hydrochloride 150 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-567 | 62332-0567-3062332-0567-90 |
| Erlotinib Hydrochloride | Erlotinib hydrochloride 25 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-080 | 72205-0080-30 |
| Erlotinib Hydrochloride | Erlotinib hydrochloride 150 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-082 | 72205-0082-30 |
Other NDCs under ANDA 214366
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 25 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-080 |
| Erlotinib Hydrochloride | Erlotinib hydrochloride 150 mg/1 | Tablet, Film coatedOral | Novadoz Pharmaceuticals LLC | 72205-082 |