Prescription drug · NDA AUTHORIZED GENERIC
Diltiazem Hydrochloride EXTENDED RELEASE (Diltiazem hydrochloride) NDC 63629-7981
Diltiazem hydrochloride 360 mg/1 · Capsule, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC DirectoryProduct NDC (as listed)63629-7981Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-7981Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-7981-1 | 63629798101 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-7981-1)Marketed from Apr 2, 2019 | |
| 63629-7981-2 | 63629798102 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-7981-2)Marketed from Feb 2, 2022 |
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 EXTENDED RELEASESuffix: EXTENDED RELEASE
- Generic name (nonproprietary)
- diltiazem hydrochloride
- Active ingredients
- Diltiazem hydrochloride — 360 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020401
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-7981_b2aa9386-ca59-470e-871f-df6c7f2a6869SPL ID b2aa9386-ca59-470e-871f-df6c7f2a6869SPL set ID 58eeb8bc-91d0-4cf8-a0d7-be3548d92196RxCUI 830795UNII 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
N463629798101followed by a unit qualifier and the quantityPackage 63629-7981-01. 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 Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive medications. Chronic Stable Angina Diltiazem hydrochloride extended-release capsules are indicated for the treatment of chronic stable angina.
Excerpt only. Read the full label for complete information.
About NDC 63629-7981
- What is NDC 63629-7981?
- 63629-7981 is the product NDC for Diltiazem Hydrochloride EXTENDED RELEASE, Diltiazem hydrochloride 360 mg/1 capsule, extended release, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diltiazem Hydrochloride EXTENDED RELEASE (Diltiazem hydrochloride).
- What is the active ingredient?
- Diltiazem hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 EXTENDED RELEASE?
- 27 other product NDCs are listed under this name. See all Diltiazem Hydrochloride EXTENDED RELEASE 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 EXTENDED RELEASE 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 Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 60 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-011 | 73190-0011-01 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-012 | 73190-0012-01 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-013 | 73190-0013-01 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 60 mg/1 | Capsule, Extended releaseOral | Dr. Reddy's Labratories Inc. | 75907-044 | 75907-0044-01 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 90 mg/1 | Capsule, Extended releaseOral | Dr. Reddy's Labratories Inc. | 75907-045 | 75907-0045-01 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Dr. Reddy's Labratories Inc. | 75907-046 | 75907-0046-01 |
| Diltiazem Hydrochloride Extended Release | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | direct rx | 72189-248 | 72189-0248-90 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Coated, Extended releaseOral | American Health Packaging | 60687-228 | 60687-0228-01 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Coated, Extended releaseOral | American Health Packaging | 60687-217 | 60687-0217-01 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Coated, Extended releaseOral | American Health Packaging | 60687-206 | 60687-0206-01 |
Other NDCs under NDA 020401
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 EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-367 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-368 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-369 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-370 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-371 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 420 mg/1 | Capsule, Extended releaseOral | Oceanside Pharmaceuticals | 68682-372 |
| Diltiazem Hydrochloride EXTENDED RELEASEdiltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-1585 |
| Diltiazem Hydrochloride Extended Release | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | direct rx | 72189-248 |
| Tiazac Extended Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Bausch Health US, LLC | 0187-2612 |
| Tiazac Extended Releasediltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Bausch Health US, LLC | 0187-2613 |
| Tiazac Extended Releasediltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Bausch Health US, LLC | 0187-2614 |
| Tiazac Extended Releasediltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Bausch Health US, LLC | 0187-2615 |
| Tiazac Extended Releasediltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Bausch Health US, LLC | 0187-2616 |
| Tiazac Extended Releasediltiazem hydrochloride | Diltiazem hydrochloride 420 mg/1 | Capsule, Extended releaseOral | Bausch Health US, LLC | 0187-2617 |