Prescription drug · ANDA
Diltiazem Hydrochloride NDC 16729-303
Diltiazem hydrochloride 120 mg/1 · Capsule, Extended release · Oral · Accord Healthcare, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-303-01 | 1672903030116729030301 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-303-01)Marketed from Sep 11, 2020 | |
| 16729-303-16 | 1672903031616729030316 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-303-16)Marketed from Sep 11, 2020 |
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 — 120 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Accord Healthcare, Inc.NDC labeler code 16729
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206997
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 16729-303_40bc87cb-ff4f-9728-e063-6294a90a9246SPL ID 40bc87cb-ff4f-9728-e063-6294a90a9246SPL set ID 70293a05-d314-43fa-a2b1-398cfb39edf8RxCUI 830837, 830845, 830861UNII OLH94387TEUPC 0316729305105
- 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
N416729030301followed by a unit qualifier and the quantityPackage 16729-0303-01. 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, USP are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. Diltiazem Hydrochloride Extended-release Capsules, USP are indicated for the management of chronic stable angina.
Excerpt only. Read the full label for complete information.
About NDC 16729-303
- What is NDC 16729-303?
- 16729-303 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 120 mg/1 capsule, extended release, listed with the FDA by Accord Healthcare, Inc.. 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?
- Accord Healthcare, Inc., NDC labeler code 16729. 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 206997
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 180 mg/1 | Capsule, Extended releaseOral | Accord Healthcare, Inc. | 16729-304 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Accord Healthcare, Inc. | 16729-305 |