Prescription drug · ANDA
Diltiazem Hydrochloride Extended-Release (Diltiazem hydrochloride) NDC 71335-1063
Diltiazem hydrochloride 180 mg/1 · Capsule, Coated, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC DirectoryProduct NDC (as listed)71335-1063Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1063Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1063-1 | 7133510630171335106301 | 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1063-1)Marketed from May 17, 2024 | |
| 71335-1063-2 | 7133510630271335106302 | 90 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE (71335-1063-2)Marketed from Jan 15, 2019 |
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 — 180 mg/1
- Dosage form
- Capsule, Coated, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074984
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-1063_6967f17c-7d4b-4c41-989f-a2e31eb7dcf9SPL ID 6967f17c-7d4b-4c41-989f-a2e31eb7dcf9SPL set ID fe7ca564-16b8-4c54-aa09-3e2ed0c2596aRxCUI 830845UNII 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
N471335106301followed by a unit qualifier and the quantityPackage 71335-1063-01. 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 is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules, USP is 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 71335-1063
- What is NDC 71335-1063?
- 71335-1063 is the product NDC for Diltiazem Hydrochloride Extended-Release, Diltiazem hydrochloride 180 mg/1 capsule, coated, 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 71335. 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 ANDA 074984
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 300 mg/1 | Capsule, Coated, Extended releaseOral | American Health Packaging | 60687-228 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 71335-0009 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1611 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 71335-0745 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1223 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 63629-2159 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 63629-2154 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 63629-2158 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Coated, Extended releaseOral | American Health Packaging | 60687-195 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Coated, Extended releaseOral | American Health Packaging | 60687-206 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Coated, Extended releaseOral | Bryant Ranch Prepack | 71335-1043 |
| Diltiazem Hydrochloride Extended-Releasediltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Coated, Extended releaseOral | American Health Packaging | 60687-217 |