Prescription drug · ANDA
Diltiazem Hydrochloride NDC 82868-036
Diltiazem hydrochloride 30 mg/1 · Tablet · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82868-036-10 | 82868003610 | 10 TABLET in 1 BOTTLE, PLASTIC (82868-036-10)Marketed from Jan 18, 2024 |
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 — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Northwind Health Company, LLCNDC labeler code 82868
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216521
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 82868-036_47f89c58-08d5-61d7-e063-6394a90a39a2SPL ID 47f89c58-08d5-61d7-e063-6394a90a39a2SPL set ID 106b33e3-b199-e555-e063-6294a90a5af5RxCUI 833217UNII 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
N482868003610followed by a unit qualifier and the quantityPackage 82868-0036-10. 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 82868-036
- What is NDC 82868-036?
- 82868-036 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 30 mg/1 tablet, listed with the FDA by Northwind Health Company, LLC. It has 1 package NDC, 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?
- Northwind Health Company, LLC, NDC labeler code 82868. 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 216521
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 | TabletOral | Coupler LLC | 67046-1560 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc | 50228-484 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc | 50228-481 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc | 50228-482 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | TabletOral | ScieGen Pharmaceuticals, Inc | 50228-483 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2373 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | TabletOral | Coupler LLC | 67046-1492 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3135 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-024 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | TabletOral | A-S Medication Solutions | 50090-7401 |