Prescription drug · ANDA
Nifedipine NDC 71335-1721
Nifedipine 60 mg/1 · Tablet, Film coated, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1721-1 | 71335172101 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1721-1)Marketed from Oct 20, 2020 | |
| 71335-1721-2 | 71335172102 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1721-2)Marketed from Oct 20, 2020 | |
| 71335-1721-3 | 71335172103 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1721-3)Marketed from Oct 20, 2020 | |
| 71335-1721-4 | 71335172104 | 28 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1721-4)Marketed from Oct 20, 2020 | |
| 71335-1721-5 | 71335172105 | 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1721-5)Marketed from Oct 20, 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)
- Nifedipine
- Generic name (nonproprietary)
- nifedipine
- Active ingredients
- Nifedipine — 60 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210614
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 71335-1721_521ef1b2-2e3f-493c-97cb-a03bc15bd79aSPL ID 521ef1b2-2e3f-493c-97cb-a03bc15bd79aSPL set ID e1cd5011-b80e-4b1b-8729-56260b8b3c26RxCUI 1812013UNII I9ZF7L6G2L
- Pharmacologic class
- Dihydropyridine Calcium Channel Blocker
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
N471335172101followed by a unit qualifier and the quantityPackage 71335-1721-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE I.Vasospastic Angina Nifedipine extended-release tablets are indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine extended-release tablets may also be used where the clinical presentation suggests a possible vasospastic com…
Excerpt only. Read the full label for complete information.
About NDC 71335-1721
- What is NDC 71335-1721?
- 71335-1721 is the product NDC for Nifedipine, Nifedipine 60 mg/1 tablet, film coated, extended release, listed with the FDA by Bryant Ranch Prepack. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nifedipine.
- What is the active ingredient?
- Nifedipine.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nifedipine?
- 124 other product NDCs are listed under this name. See all Nifedipine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nifedipine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Coupler LLC | 67046-0260 | 67046-0260-03 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4625 | 70518-4625-00 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0196 | 55154-0196-00 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-862 | 60760-0862-90 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-859 | 60760-0859-90 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-386 | 51655-0386-52 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-593 | 51655-0593-26 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-732 | 46708-0732-3146708-0732-6346708-0732-91 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-733 | 46708-0733-3146708-0733-63 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-734 | 46708-0734-31 |
Other NDCs under ANDA 210614
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 |
|---|---|---|---|---|
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8549 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-7081 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-7082 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6201 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6203 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6450 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-260 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-261 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-262 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-386 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-407 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-593 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 107, LLC | 55154-4157 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-859 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Film coated, Extended releaseOral | St. Mary's Medical Park Pharmacy | 60760-862 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Coupler LLC | 67046-0260 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-2619 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals, Inc. | 68788-7642 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Film coated, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8164 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-2679 |
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