Prescription drug · ANDA
Diltiazem Hydrochloride NDC 70436-192
Diltiazem hydrochloride 180 mg/1 · Capsule, Extended release · Oral · Slate Run Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-192-01 | 70436019201 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-192-01)Marketed from Sep 5, 2022 | |
| 70436-192-02 | 70436019202 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70436-192-02)Marketed from Sep 5, 2022 |
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 — 180 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216304
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 70436-192_584a0d75-656b-7918-e063-6294a90a278eSPL ID 584a0d75-656b-7918-e063-6294a90a278eSPL set ID e66665e8-22eb-f5cd-e053-2a95a90a72e4RxCUI 830837, 830845, 830861UNII OLH94387TEUPC 0370436192014, 0370436193028, 0370436192021, 0370436193011, 0370436191017
- 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
N470436019201followed by a unit qualifier and the quantityPackage 70436-0192-01. 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 are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem Hydrochloride Extended-Release Capsules are indicated for the management of chronic stable angina.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 216304
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 | Slate Run Pharmaceuticals, LLC | 70436-191 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Slate Run Pharmaceuticals, LLC | 70436-193 |