Prescription drug · ANDA
Diltiazem Hydrochloride Extended-Release NDC 75907-044
diltiazem hydrochloride · Diltiazem hydrochloride 60 mg/1 · Capsule, Extended release · Oral · Dr. Reddy's Labratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-044-01 | 75907004401 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (75907-044-01)Marketed from Sep 10, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 Extended-Release
- Generic name (nonproprietary)
- diltiazem hydrochloride
- Active ingredients
- Diltiazem hydrochloride — 60 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Dr. Reddy's Labratories Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215775
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 75907-044_09bae4f6-ad9c-88db-a26b-3236e0f9022cSPL ID 09bae4f6-ad9c-88db-a26b-3236e0f9022cSPL set ID f1d09c53-5eb9-0b7c-e977-e2a602e84e5fRxCUI 830865, 830869, 830872UNII OLH94387TE
- 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
N475907004401followed by a unit qualifier and the quantityPackage 75907-0044-01. 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 Diltiazem Hydrochloride Extended-Release Capsules (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215775
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 Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | Dr. Reddy's Labratories Inc. | 75907-045 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Dr. Reddy's Labratories Inc. | 75907-046 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-013 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 60 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-011 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-012 |