Prescription drug · ANDA
Nifedipine NDC 68071-2838
Nifedipine 30 mg/1 · Tablet, Extended release · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2838-3 | 6807128380368071283803 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-2838-3)Marketed from Dec 8, 2022 |
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 — 30 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213361
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 68071-2838_27d6c9c5-5a46-9cfc-e063-6394a90a7202SPL ID 27d6c9c5-5a46-9cfc-e063-6394a90a7202SPL set ID 27d6c9c5-5a45-9cfc-e063-6394a90a7202RxCUI 198034UNII I9ZF7L6G2LUPC 0368071283839
- 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
N468071283803followed by a unit qualifier and the quantityPackage 68071-2838-03. 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 .
Indications (excerpt from the label)
INDICATION AND USAGE Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Excerpt only. Read the full label for complete information.
About NDC 68071-2838
- What is NDC 68071-2838?
- 68071-2838 is the product NDC for Nifedipine, Nifedipine 30 mg/1 tablet, extended release, listed with the FDA by NuCare Pharmaceuticals,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?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 | 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 213361
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 30 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 59651-295 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 59651-296 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Aurobindo Pharma Limited | 59651-297 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Redpharm Drug | 67296-2170 |
| Nifedipine | Nifedipine 30 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2534 |
| Nifedipine | Nifedipine 60 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2535 |
| Nifedipine | Nifedipine 90 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2536 |