Prescription drug · ANDA
Diltiazem Hydrochloride NDC 71335-0266
Diltiazem hydrochloride 180 mg/1 · Capsule, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0266-1 | 71335026601 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0266-1)Marketed from Oct 8, 2024 | |
| 71335-0266-2 | 71335026602 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-0266-2)Marketed from Oct 8, 2024 |
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
- Generic name (nonproprietary)
- diltiazem hydrochloride
- Active ingredients
- Diltiazem hydrochloride — 180 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074943
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-0266_6683d029-699c-4779-9c14-717818362b62SPL ID 6683d029-699c-4779-9c14-717818362b62SPL set ID 3a620125-898a-47ba-9000-4295c3a3ad72RxCUI 830845UNII 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
N471335026601followed by a unit qualifier and the quantityPackage 71335-0266-01. 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 DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage)] are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. DILT-XR [Diltiazem Hydrochloride Extended-Release Capsules, USP (Once-a-day dosage)] are indicated for the management of chronic stable angina.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 074943
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 180 mg/1 | Capsule, Extended releaseOral | Apotex Corp. | 60505-0015 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Apotex Corp. | 60505-0014 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Apotex Corp. | 60505-0016 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | NORTHSTAR RX LLC | 16714-523 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | NORTHSTAR RX LLC | 16714-524 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | NORTHSTAR RX LLC | 16714-525 |