Prescription drug · ANDA
Diltiazem Hydrochloride NDC 50090-0451
Diltiazem hydrochloride 60 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-0451-2 | 50090045102 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-0451-2)Marketed from Jun 29, 2016 | |
| 50090-0451-3 | 50090045103 | 90 TABLET, FILM COATED in 1 BOTTLE (50090-0451-3)Marketed from May 16, 2018 |
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 — 60 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074185
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-0451_6113069e-e767-42d1-a59a-5001924df02cSPL ID 6113069e-e767-42d1-a59a-5001924df02cSPL set ID e99e1446-9c85-478c-9e23-a5f4104bbd22RxCUI 831103UNII 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
N450090045102followed by a unit qualifier and the quantityPackage 50090-0451-02. 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 tablets 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 50090-0451
- What is NDC 50090-0451?
- 50090-0451 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 60 mg/1 tablet, film coated, 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 | 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 | TabletOral | Zydus Lifesciences Limited | 70771-1930 | 70771-1930-0170771-1930-05 |
| Diltiazem hydrochloride | Diltiazem hydrochloride 30 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1929 | 70771-1929-0170771-1929-05 |
| 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 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 074185
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 30 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-0318 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-0319 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-0320 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-0321 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8032 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8033 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-020 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-717 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-728 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-769 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-3659 |