Prescription drug · ANDA
Diltiazem hydrochloride NDC 50090-6328
Diltiazem hydrochloride 120 mg/1 · Capsule, Extended release · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6328-0 | 50090632800 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-6328-0)Marketed from Jan 13, 2023 | |
| 50090-6328-1 | 50090632801 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-6328-1)Marketed from Jan 13, 2023 |
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 — 120 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203023
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)
- Identifiers
- Product ID 50090-6328_d786e289-37d8-4cb3-9bf0-967fbd5ebc2bSPL ID d786e289-37d8-4cb3-9bf0-967fbd5ebc2bSPL set ID 5460158f-7782-45f4-89b1-f84e6ba178d8RxCUI 830861UNII 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
N450090632800followed by a unit qualifier and the quantityPackage 50090-6328-00. 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 are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP 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.
About NDC 50090-6328
- What is NDC 50090-6328?
- 50090-6328 is the product NDC for Diltiazem hydrochloride, Diltiazem hydrochloride 120 mg/1 capsule, extended release, listed with the FDA by A-S Medication Solutions. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diltiazem hydrochloride.
- What is the active ingredient?
- Diltiazem hydrochloride.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diltiazem hydrochloride?
- 220 other product NDCs are listed under this name. See all Diltiazem hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diltiazem hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diltiazem hydrochloride | Diltiazem hydrochloride 30 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1929 | 70771-1929-0170771-1929-05 |
| Diltiazem hydrochloride | Diltiazem hydrochloride 60 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1930 | 70771-1930-0170771-1930-05 |
| Diltiazem hydrochloride | Diltiazem hydrochloride 90 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1931 | 70771-1931-0170771-1931-05 |
| Diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1932 | 70771-1932-0170771-1932-05 |
| Diltiazem hydrochloride | Diltiazem hydrochloride 30 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-199 | 72578-0199-0172578-0199-05 |
| Diltiazem hydrochloride | Diltiazem hydrochloride 60 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-200 | 72578-0200-0172578-0200-05 |
| Diltiazem hydrochloride | Diltiazem hydrochloride 90 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-201 | 72578-0201-0172578-0201-05 |
| Diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-202 | 72578-0202-0172578-0202-05 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Safecor Health LLC | 48433-030 | 48433-0030-20 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | Safecor Health LLC | 48433-031 | 48433-0031-20 |
Other NDCs under ANDA 203023
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 | Sun Pharmaceutical Industries, Inc. | 63304-718 |
| Diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-719 |
| Diltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-720 |
| Diltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-721 |
| Diltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 63304-722 |