Prescription drug · ANDA
Diltiazem Hydrochloride NDC 46708-784
Diltiazem hydrochloride 120 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-784-31 | 46708078431 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-784-31)Marketed from Nov 14, 2025 | |
| 46708-784-71 | 46708078471 | 500 TABLET, FILM COATED in 1 BOTTLE (46708-784-71)Marketed from Nov 14, 2025 |
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
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217633
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-784_74bab197-f719-48c0-ac84-c0cf0087b45aSPL ID 74bab197-f719-48c0-ac84-c0cf0087b45aSPL set ID 74bab197-f719-48c0-ac84-c0cf0087b45aRxCUI 831054, 831102, 831103, 833217UNII OLH94387TEUPC 0346708783310, 0346708784317
- 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
N446708078431followed by a unit qualifier and the quantityPackage 46708-0784-31. 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 46708-784
- What is NDC 46708-784?
- 46708-784 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 120 mg/1 tablet, film coated, listed with the FDA by Alembic Pharmaceuticals Limited. 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 | 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 |
| 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 | 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 217633
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 | Alembic Pharmaceuticals Inc. | 62332-781 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-782 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-783 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 120 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Inc. | 62332-784 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 30 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-781 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 60 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-782 |
| Diltiazem Hydrochloride | Diltiazem hydrochloride 90 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-783 |