Prescription drug · ANDA
Diltiazem Hydrochloride NDC 48433-030
Diltiazem hydrochloride 60 mg/1 · Capsule, Extended release · Oral · Safecor Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48433-030-20 | 48433003020 | 100 BLISTER PACK in 1 CARTON (48433-030-20) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (48433-030-01)Marketed from Feb 2, 2026 |
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
- Generic name (nonproprietary)
- diltiazem hydrochloride
- Active ingredients
- Diltiazem hydrochloride — 60 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Safecor Health LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074910
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 48433-030_597d848a-68cd-6404-e063-6294a90abd16SPL ID 597d848a-68cd-6404-e063-6294a90abd16SPL set ID fc02db0f-5311-4b61-896e-bfe340832735RxCUI 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
N448433003020followed by a unit qualifier and the quantityPackage 48433-0030-20. 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 074910
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 120 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-6120 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-6060 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-6090 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Mylan Institutional Inc. | 51079-924 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | Mylan Institutional Inc. | 51079-925 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Mylan Institutional Inc. | 51079-926 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-1481 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | Safecor Health LLC | 48433-031 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Safecor Health LLC | 48433-032 |