Prescription drug · ANDA
Diltiazem Hydrochloride NDC 67046-1481
Diltiazem hydrochloride 120 mg/1 · Capsule, Extended release · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1481-3 | 6704614810367046148103 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1481-3)Marketed from Jan 30, 2025 |
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
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074910
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 67046-1481_2ced5dc5-47e0-1b71-e063-6394a90a0e3dSPL ID 2ced5dc5-47e0-1b71-e063-6394a90a0e3dSPL set ID 2ced821f-19a6-4c7e-e063-6394a90adb80RxCUI 830872UNII 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
N467046148103followed by a unit qualifier and the quantityPackage 67046-1481-03. 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 (Twice-a-Day Dosage) are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications, such as diuretics.
Excerpt only. Read the full label for complete information.
About NDC 67046-1481
- What is NDC 67046-1481?
- 67046-1481 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 120 mg/1 capsule, extended release, listed with the FDA by Coupler 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?
- Coupler LLC, NDC labeler code 67046. 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?
- 223 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 60 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-322 | 27808-0322-01 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-323 | 27808-0323-01 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-324 | 27808-0324-01 |
| 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 |
Other NDCs under ANDA 074910
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 60 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-6060 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-6090 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-6120 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Safecor Health LLC | 48433-030 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | Safecor Health LLC | 48433-031 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Safecor Health LLC | 48433-032 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Mylan Institutional Inc. | 51079-924 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | Mylan Institutional Inc. | 51079-925 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Mylan Institutional Inc. | 51079-926 |