Prescription drug · ANDA
diltiazem hydrochloride NDC 50742-251
Diltiazem hydrochloride 300 mg/1 · Capsule, Extended release · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-251-05 | 50742025105 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-05)Marketed from Jun 14, 2019 | |
| 50742-251-10 | 50742025110 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-10)Marketed from Jun 14, 2019 | |
| 50742-251-30 | 50742025130 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-30)Marketed from Jun 14, 2019 | |
| 50742-251-90 | 50742025190 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-251-90)Marketed from Jun 14, 2019 |
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 — 300 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Ingenus Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208783
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 50742-251_d52d40db-f91a-49ea-ac2f-88a56f429421SPL ID d52d40db-f91a-49ea-ac2f-88a56f429421SPL set ID 355f560a-8ebb-4661-ad74-2a22f707d7f8RxCUI 830795, 830801, 830837, 830845, 830861UNII OLH94387TEUPC 0350742248308, 0350742249305, 0350742250301
- 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
N450742025105followed by a unit qualifier and the quantityPackage 50742-0251-05. 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. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules are 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 208783
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 | Preferred Pharmaceuticals Inc. | 68788-7870 |
| diltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-252 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-249 |
| diltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-250 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2602 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-1776 |
| diltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-3091 |
| Diltiazem HCL ER | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Direct_Rx | 72189-409 |
| diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2089 |
| diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-248 |
| diltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-1897 |
| diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8379 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8380 |
| diltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8381 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-040 |
| diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-039 |
| diltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-042 |
| diltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-041 |
| diltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-043 |
| diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-3484 |