Prescription drug · ANDA
Erlotinib NDC 70771-1521
Erlotinib hydrochloride 25 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1521-3 | 7077115210370771152103 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1521-3)Marketed from Apr 30, 2020 | |
| 70771-1521-7 | 7077115210770771152107 | 3 BLISTER PACK in 1 CARTON (70771-1521-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1521-2)Marketed from Apr 30, 2020 | |
| 70771-1521-9 | 7077115210970771152109 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1521-9)Marketed from Apr 30, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213065
- Marketing start
- Listing expires
- Other FDA classes
- Protein Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1521_9d253beb-cd1f-45df-9b23-c521269d419fSPL ID 9d253beb-cd1f-45df-9b23-c521269d419fSPL set ID daaa1329-3a3f-439c-b13d-b301daa234d4RxCUI 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
N470771152103followed by a unit qualifier and the quantityPackage 70771-1521-03. 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 .
About NDC 70771-1521
- What is NDC 70771-1521?
- 70771-1521 is the product NDC for Erlotinib, Erlotinib hydrochloride 25 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 3 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?
- Zydus Lifesciences Limited, NDC labeler code 70771. 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 213065
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 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-913 |
| Erlotinib | Erlotinib hydrochloride 100 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-914 |
| Erlotinib | Erlotinib hydrochloride 150 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-915 |
| Erlotinib | Erlotinib hydrochloride 100 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1522 |
| Erlotinib | Erlotinib hydrochloride 150 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1523 |