Prescription drug · ANDA
Diltiazem Hydrochloride NDC 68071-4664
Diltiazem hydrochloride 120 mg/1 · Capsule, Extended release · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-4664-3 | 68071466403 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4664-3)Marketed from Dec 12, 2018 |
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)
- Diltiazem Hydrochloride
- Generic name (nonproprietary)
- diltiazem hydrochloride
- Active ingredients
- Diltiazem hydrochloride — 120 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075116
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-4664_1ab86011-6c6d-e459-e063-6394a90a20ddSPL ID 1ab86011-6c6d-e459-e063-6394a90a20ddSPL set ID 7cdb473a-e6d5-48e8-e053-2a91aa0aaeb7RxCUI 830861UNII OLH94387TEUPC 0368071466430
- Pharmacologic class
- 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
N468071466403followed by a unit qualifier and the quantityPackage 68071-4664-03. 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)
INDICATIONS AND USAGE Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules (Once-a-Day Dosage) are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 075116
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 |
|---|---|---|---|---|
| Diltiazem Hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | NuCare Pharmaceuticals,Inc. | 68071-4005 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | OCEANSIDE PHARMACEUTICALS | 68682-997 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | OCEANSIDE PHARMACEUTICALS | 68682-998 |
| Diltiazem Hydrochloride | Diltiazem HCl 240 mg/1 | Capsule, Extended releaseOral | A-S Medication Solutions | 50090-7815 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-0867 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-1389 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | OCEANSIDE PHARMACEUTICALS | 68682-994 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | OCEANSIDE PHARMACEUTICALS | 68682-993 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-0634 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-0643 |