Prescription drug · ANDA
Diltiazem Hydrochloride Extended-Release NDC 71335-0009
diltiazem hydrochloride · Diltiazem hydrochloride 240 mg/1 · Capsule, Coated, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0009-1 | 71335000901 | 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0009-1)Marketed from May 4, 2022 | |
| 71335-0009-2 | 71335000902 | 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0009-2)Marketed from May 4, 2022 | |
| 71335-0009-3 | 71335000903 | 18 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0009-3)Marketed from May 4, 2022 |
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 Extended-ReleaseSuffix: Extended-Release
- Generic name (nonproprietary)
- diltiazem hydrochloride
- Active ingredients
- Diltiazem hydrochloride — 240 mg/1
- Dosage form
- Capsule, Coated, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074984
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-0009_ceaca8e0-d681-4458-9a5a-2eb9e770755cSPL ID ceaca8e0-d681-4458-9a5a-2eb9e770755cSPL set ID de2a0c48-7fc4-4760-b465-a79299876e6eRxCUI 830837UNII 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
N471335000901followed by a unit qualifier and the quantityPackage 71335-0009-01. 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, USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is 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 074984
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 300 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 63629-2159 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 63629-2154 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 63629-2158 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1043 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1063 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Coated, Extended releaseOral | American Health Packaging | 60687-195 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Coated, Extended releaseOral | American Health Packaging | 60687-206 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Coated, Extended releaseOral | American Health Packaging | 60687-217 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Coated, Extended releaseOral | American Health Packaging | 60687-228 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1611 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1223 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 71335-0745 |