Prescription drug · ANDA
Diltiazem Hydrochloride NDC 47335-671
Diltiazem hydrochloride 240 mg/1 · Capsule, Extended release · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-671-13 | 47335067113 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-671-13)Marketed from Nov 15, 2010 | |
| 47335-671-18 | 47335067118 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-671-18)Marketed from Nov 15, 2010 | |
| 47335-671-19 | 47335067119 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-671-19)Marketed from Nov 15, 2010 | |
| 47335-671-81 | 47335067181 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-671-81)Marketed from Nov 15, 2010 | |
| 47335-671-83 | 47335067183 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-671-83)Marketed from Nov 15, 2010 |
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 — 240 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090421
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 47335-671_ecddf1f1-b8e7-4a08-8f00-6cc484092a5fSPL ID ecddf1f1-b8e7-4a08-8f00-6cc484092a5fSPL set ID eebf29fe-ce22-4482-b850-5854550bf2c4RxCUI 830795, 830801, 830837, 830845, 830861UNII OLH94387TEUPC 0347335672831, 0347335673838, 0347335671834
- 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
N447335067113followed by a unit qualifier and the quantityPackage 47335-0671-13. 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: Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Chronic Stable Angina: Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090421
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 300 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-672 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-669 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-670 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-673 |