Prescription drug · ANDA
AMLODIPINE BESYLATE 10 mg (Amlodipine besylate) NDC 68788-8451
Amlodipine besylate 10 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8451-1 | 6878884510168788845101 | 100 TABLET in 1 BOTTLE (68788-8451-1)Marketed from May 30, 2023 | |
| 68788-8451-3 | 6878884510368788845103 | 30 TABLET in 1 BOTTLE (68788-8451-3)Marketed from May 30, 2023 | |
| 68788-8451-6 | 6878884510668788845106 | 60 TABLET in 1 BOTTLE (68788-8451-6)Marketed from May 30, 2023 | |
| 68788-8451-9 | 6878884510968788845109 | 90 TABLET in 1 BOTTLE (68788-8451-9)Marketed from May 30, 2023 |
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)
- AMLODIPINE BESYLATE 10 mgSuffix: 10 mg
- Generic name (nonproprietary)
- amlodipine besylate
- Active ingredients
- Amlodipine besylate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078414
- Marketing start
- Listing expires
- Other FDA classes
- Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
- Identifiers
- Product ID 68788-8451_57f51242-eb35-4bb6-8a3b-3d0f43b1966eSPL ID 57f51242-eb35-4bb6-8a3b-3d0f43b1966eSPL set ID ea9f44a1-96cf-496a-8c07-18d8de27e512RxCUI 308135UNII 864V2Q084H
- Pharmacologic class
- Calcium Channel Blocker; Dihydropyridine 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
N468788845101followed by a unit qualifier and the quantityPackage 68788-8451-01. 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)
Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: • Hypertension () o Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. • Coronary Artery Disease () o Chronic Stable Angina o Vasospastic Angina (Prinzmetal's or Variant Angina) o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besylate tablets are …
Excerpt only. Read the full label for complete information.
About NDC 68788-8451
- What is NDC 68788-8451?
- 68788-8451 is the product NDC for AMLODIPINE BESYLATE 10 mg (amlodipine besylate), Amlodipine besylate 10 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- AMLODIPINE BESYLATE 10 mg (Amlodipine besylate).
- What is the active ingredient?
- Amlodipine besylate.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for AMLODIPINE BESYLATE 10 mg?
- 6 other product NDCs are listed under this name. See all AMLODIPINE BESYLATE 10 mg NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other AMLODIPINE BESYLATE 10 mg products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| AMLODIPINE BESYLATE 10 mgamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3453 | 68071-3453-0268071-3453-0368071-3453-09 |
| AMLODIPINE BESYLATE 10 mgamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-023 | 69584-0023-0969584-0023-5069584-0023-90+2 more |
| AMLODIPINE BESYLATE 10 mgamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-830 | 71610-0830-3071610-0830-4571610-0830-60 |
| AMLODIPINE BESYLATE 10 mgamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-978 | 71610-0978-3071610-0978-4571610-0978-53+1 more |
| AMLODIPINE BESYLATE 10 mgamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-262 | 72789-0262-3072789-0262-6072789-0262-90+1 more |
| AMLODIPINE BESYLATE 10 mgamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | Proficient Rx LP | 82804-971 | 82804-0971-0082804-0971-1182804-0971-30+4 more |
Other NDCs under ANDA 078414
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 |
|---|---|---|---|---|
| AMLODIPINE BESYLATE 10 mgamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3453 |
| AMLODIPINE BESYLATE 5 mgamlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-687 |
| AMLODIPINE BESYLATE 2.5 mgamlodipine besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-021 |
| AMLODIPINE BESYLATE 5 mgamlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-022 |
| AMLODIPINE BESYLATE 10 mgamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | Oxford Pharmaceuticals, LLC | 69584-023 |
| AMLODIPINE BESYLATE 10 mgamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-978 |
| AMLODIPINE BESYLATE 5 mgamlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-985 |
| AMLODIPINE BESYLATE 5 mgamlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-261 |
| AMLODIPINE BESYLATE 2.5 mgamlodipine besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-260 |
| AMLODIPINE BESYLATE 10 mgamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-262 |
| AMLODIPINE BESYLATE 2.5 mgamlodipine besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-802 |
| AMLODIPINE BESYLATE 10 mgamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | Proficient Rx LP | 82804-971 |
| AMLODIPINE BESYLATE 2.5 mgamlodipine besylate | Amlodipine besylate 2.5 mg/1 | TabletOral | Proficient Rx LP | 82804-969 |
| AMLODIPINE BESYLATE 5 mgamlodipine besylate | Amlodipine besylate 5 mg/1 | TabletOral | Proficient Rx LP | 82804-970 |
| AMLODIPINE BESYLATE 10 mgamlodipine besylate | Amlodipine besylate 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-830 |