Prescription drug · ANDA
Diltiazem HCL ER NDC 72189-409
Diltiazem hydrochloride 300 mg/1 · Capsule, Extended release · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-409-90 | 72189040990 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-409-90)Marketed from Jan 10, 2023 |
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 HCL ER
- Generic name (nonproprietary)
- diltiazem hcl er
- Active ingredients
- Diltiazem hydrochloride — 300 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208783
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
- Identifiers
- Product ID 72189-409_2c4ce2c4-2b19-de10-e063-6394a90ad371SPL ID 2c4ce2c4-2b19-de10-e063-6394a90ad371SPL set ID f1ea85b2-ecd2-5867-e053-2a95a90a24dcRxCUI 830801UNII 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
N472189040990followed by a unit qualifier and the quantityPackage 72189-0409-90. 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)
Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem hydrochloride extended-release capsules 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 72189-409
- What is NDC 72189-409?
- 72189-409 is the product NDC for Diltiazem HCL ER, Diltiazem hydrochloride 300 mg/1 capsule, extended release, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diltiazem HCL ER.
- What is the active ingredient?
- Diltiazem hydrochloride.
- Who is the labeler?
- Direct_Rx, NDC labeler code 72189. 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 HCL ER?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 208783
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 120 mg/1 | Capsule, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8379 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8380 |
| diltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8381 |
| diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-248 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-249 |
| diltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-250 |
| diltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-251 |
| diltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-252 |
| diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-7870 |
| diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-3484 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-1776 |
| diltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-1897 |
| diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2089 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-2602 |
| diltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-3091 |
| diltiazem hydrochloride | Diltiazem hydrochloride 120 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-039 |
| diltiazem hydrochloride | Diltiazem hydrochloride 180 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-040 |
| diltiazem hydrochloride | Diltiazem hydrochloride 240 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-041 |
| diltiazem hydrochloride | Diltiazem hydrochloride 300 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-042 |
| diltiazem hydrochloride | Diltiazem hydrochloride 360 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 84677-043 |