Prescription drug · ANDA
Nifedipine NDC 70518-4625
Nifedipine 10 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4625-0 | 7051846250070518462500 | 50 POUCH in 1 BOX (70518-4625-0) / 1 CAPSULE in 1 POUCH (70518-4625-1)Marketed from Apr 24, 2026 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202644
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 70518-4625_503ac20c-0b86-83cf-e063-6294a90a0ee7SPL ID 503ac20c-0b86-83cf-e063-6294a90a0ee7SPL set ID bddfd658-ac61-4ba2-a3fa-07acc35d368aRxCUI 198032UNII 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
N470518462500followed by a unit qualifier and the quantityPackage 70518-4625-00. 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 is 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 may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed,…
Excerpt only. Read the full label for complete information.
About NDC 70518-4625
- What is NDC 70518-4625?
- 70518-4625 is the product NDC for Nifedipine, Nifedipine 10 mg/1 capsule, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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?
- 127 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 | 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 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-732 | 62332-0732-3162332-0732-6362332-0732-91 |
Other NDCs under ANDA 202644
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 10 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7229 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-194 |
| Nifedipine | Nifedipine 20 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-195 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0196 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-739 |
| Nifedipine | Nifedipine 20 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-740 |
| Nifedipine | Nifedipine 10 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-219 |