Prescription drug · ANDA
diltiazem hydrochloride NDC 70771-1034
Diltiazem hydrochloride 360 mg/1 · Capsule, Extended release · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1034-1 | 70771103401 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1034-1)Marketed from Sep 28, 2017 | |
| 70771-1034-3 | 70771103403 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1034-3)Marketed from Sep 28, 2017 | |
| 70771-1034-4 | 70771103404 | 10 BLISTER PACK in 1 CARTON (70771-1034-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 28, 2017 | |
| 70771-1034-5 | 70771103405 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1034-5)Marketed from Oct 2, 2018 | |
| 70771-1034-9 | 70771103409 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1034-9)Marketed from Sep 28, 2017 |
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 — 360 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206534
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1034_99889af0-9650-495d-9834-3cb0e77cda5eSPL ID 99889af0-9650-495d-9834-3cb0e77cda5eSPL set ID fe790439-85d4-4cd8-a385-149ea3442a38RxCUI 830795, 830801, 830837, 830845, 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
N470771103401followed by a unit qualifier and the quantityPackage 70771-1034-01. 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.
About NDC 70771-1034
- What is NDC 70771-1034?
- 70771-1034 is the product NDC for diltiazem hydrochloride, Diltiazem hydrochloride 360 mg/1 capsule, extended release, listed with the FDA by Zydus Lifesciences Limited. It has 5 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?
- Zydus Lifesciences Limited, NDC labeler code 70771. 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 206534
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 | Zydus Pharmaceuticals (USA) Inc. | 68382-595 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-596 |
| diltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-597 |
| diltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-598 |
| diltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-599 |
| diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1030 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1031 |
| diltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1032 |
| diltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1033 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-9708 |