Prescription drug · ANDA
Ranolazine NDC 70771-1500
Ranolazine 1000 mg/1 · Tablet, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1500-1 | 70771150001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1500-1)Marketed from Sep 10, 2019 | |
| 70771-1500-4 | 70771150004 | 10 BLISTER PACK in 1 CARTON (70771-1500-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1500-2)Marketed from Sep 10, 2019 | |
| 70771-1500-5 | 70771150005 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1500-5)Marketed from Sep 10, 2019 | |
| 70771-1500-6 | 70771150006 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1500-6)Marketed from Sep 10, 2019 |
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)
- Ranolazine
- Generic name (nonproprietary)
- ranolazine
- Active ingredients
- Ranolazine — 1000 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210188
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1500_0d292500-31c7-444f-aee2-364fcdf09448SPL ID 0d292500-31c7-444f-aee2-364fcdf09448
- Pharmacologic class
- Anti-anginal
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
N470771150001followed by a unit qualifier and the quantityPackage 70771-1500-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70771-1500
- What is NDC 70771-1500?
- 70771-1500 is the product NDC for Ranolazine, Ranolazine 1000 mg/1 tablet, extended release, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ranolazine.
- What is the active ingredient?
- Ranolazine.
- 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 Ranolazine?
- 53 other product NDCs are listed under this name. See all Ranolazine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ranolazine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Extended releaseOral | Umedica Laboratories USA Inc. | 60290-056 | 60290-0056-0160290-0056-03 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Extended releaseOral | Umedica Laboratories USA Inc. | 60290-055 | 60290-0055-0160290-0055-03 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | Torrent Pharma, Inc. | 13668-759 | 13668-0759-60 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Torrent Pharma, Inc. | 13668-760 | 13668-0760-60 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | Zameer Pharmaceuticals LLC | 90096-151 | 90096-0151-60 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Zameer Pharmaceuticals LLC | 90096-152 | 90096-0152-60 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | Radha Pharmaceuticals, Inc | 77771-423 | 77771-0423-60 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Film coated, Extended releaseOral | Radha Pharmaceuticals, Inc | 77771-424 | 77771-0424-60 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-971 | 71610-0971-42 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Film coated, Extended releaseOral | A2A Integrated Pharmaceuticals | 73141-022 | 73141-0022-02 |
Other NDCs under ANDA 210188
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 |
|---|---|---|---|---|
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Extended releaseOral | Zydus Lifesciences Limited | 70771-1499 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8611 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Extended releaseOral | Viona Pharmaceuticals Inc | 72578-064 |
| Ranolazine | Ranolazine 1000 mg/1 | Tablet, Extended releaseOral | Viona Pharmaceuticals Inc | 72578-065 |
| Ranolazine | Ranolazine 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 63629-4874 |