Prescription drug · NDA
Tiazac Extended Release (diltiazem hydrochloride) NDC 0187-2617
Diltiazem hydrochloride 420 mg/1 · Capsule, Extended release · Oral · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-2617-30 | 00187261730 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2617-30)Marketed from Aug 20, 2014 | |
| 0187-2617-90 | 00187261790 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2617-90)Marketed from Aug 20, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Tiazac Extended ReleaseSuffix: EXTENDED RELEASE
- Generic name (nonproprietary)
- diltiazem hydrochloride
- Active ingredients
- Diltiazem hydrochloride — 420 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Bausch Health US, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020401
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 0187-2617_d16e7ace-3d95-4196-a7b0-cdd26f3bd8e7SPL ID d16e7ace-3d95-4196-a7b0-cdd26f3bd8e7SPL set ID c567fe7e-887e-4291-a0d1-2dd3f25cbf25RxCUI 830795, 830801, 830837, 830845, 830861, 831193, 831244, 831296, 831323, 831347, 831359, 831360UNII 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
N400187261730followed by a unit qualifier and the quantityPackage 00187-2617-30. 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 Hypertension Tiazac is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Chronic Stable Angina Tiazac is indicated for the treatment of chronic stable angina.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020401
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 |
|---|---|---|---|---|
| Tiazac Extended Releasediltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Bausch Health US, LLC | 0187-2613 |
| Tiazac Extended Releasediltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Bausch Health US, LLC | 0187-2614 |
| Tiazac Extended Releasediltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Bausch Health US, LLC | 0187-2615 |
| Tiazac Extended Releasediltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Bausch Health US, LLC | 0187-2616 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-1585 |
| Diltiazem Hydrochloride Extended Release | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | direct rx | 72189-248 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-368 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-367 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-369 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-370 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-371 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 420 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-372 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-7981 |
| Tiazac Extended Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Bausch Health US, LLC | 0187-2612 |
- openFDA data updated
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