Prescription drug · ANDA
Tiadylt ER (Diltiazem hydrochloride) NDC 68382-748
Diltiazem hydrochloride 300 mg/1 · Capsule, Extended release · Oral · Zydus Pharmaceuticals (USA) Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-748-01 | 68382074801 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-01)Marketed from Nov 8, 2017 | |
| 68382-748-05 | 68382074805 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-05)Marketed from Nov 8, 2017 | |
| 68382-748-06 | 68382074806 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-06)Marketed from Nov 8, 2017 | |
| 68382-748-10 | 68382074810 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-10)Marketed from Nov 8, 2017 | |
| 68382-748-16 | 68382074816 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-748-16)Marketed from Nov 8, 2017 |
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)
- Tiadylt ER
- Generic name (nonproprietary)
- diltiazem hydrochloride
- Active ingredients
- Diltiazem hydrochloride — 300 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals (USA) Inc.NDC labeler code 68382
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206641
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 68382-748_16e01600-83e9-4996-8b2b-c175d92a205aSPL ID 16e01600-83e9-4996-8b2b-c175d92a205aSPL set ID 1278cd76-b8e9-42d9-ad19-6858e72cf9f2RxCUI 830795, 830801, 830837, 830845, 830861, 831359, 1988308, 1988311, 1988316, 1988319, 1988324, 1988330UNII OLH94387TEUPC 0368382749161
- 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
N468382074801followed by a unit qualifier and the quantityPackage 68382-0748-01. 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 Hypertension: Tiadylt ® ER capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Chronic Stable Angina: Tiadylt ® ER capsules are indicated for the treatment of chronic stable angina.
Excerpt only. Read the full label for complete information.
About NDC 68382-748
- What is NDC 68382-748?
- 68382-748 is the product NDC for Tiadylt ER (diltiazem hydrochloride), Diltiazem hydrochloride 300 mg/1 capsule, extended release, listed with the FDA by Zydus Pharmaceuticals (USA) Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tiadylt ER (Diltiazem hydrochloride).
- What is the active ingredient?
- Diltiazem hydrochloride.
- Who is the labeler?
- Zydus Pharmaceuticals (USA) Inc., NDC labeler code 68382. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tiadylt ER?
- 12 other product NDCs are listed under this name. See all Tiadylt ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tiadylt ER products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-745 | 68382-0745-0168382-0745-0568382-0745-06+2 more |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-746 | 68382-0746-0168382-0746-0568382-0746-06+2 more |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-747 | 68382-0747-0168382-0747-0568382-0747-06+2 more |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-749 | 68382-0749-0168382-0749-0568382-0749-06+2 more |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 420 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-750 | 68382-0750-0168382-0750-0568382-0750-06+2 more |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1035 | 70771-1035-0070771-1035-0170771-1035-03+2 more |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1036 | 70771-1036-0070771-1036-0170771-1036-03+2 more |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1037 | 70771-1037-0070771-1037-0170771-1037-03+2 more |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1038 | 70771-1038-0070771-1038-0170771-1038-03+2 more |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1039 | 70771-1039-0070771-1039-0170771-1039-03+2 more |
Other NDCs under ANDA 206641
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 |
|---|---|---|---|---|
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-745 |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-746 |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-747 |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-749 |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 420 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals (USA) Inc. | 68382-750 |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1035 |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1036 |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1037 |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1038 |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1039 |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 420 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1040 |
| Tiadylt ERdiltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-9719 |