Prescription drug · ANDA
Loperamide Hydrochloride NDC 66267-132
Loperamide hydrochloride 2 mg/1 · Capsule · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66267-132-12 | 66267013212 | 12 CAPSULE in 1 BOTTLE (66267-132-12)Marketed from Oct 10, 2016 | |
| 66267-132-15 | 66267013215 | 15 CAPSULE in 1 BOTTLE (66267-132-15)Marketed from Oct 10, 2016 | |
| 66267-132-18 | 66267013218 | 18 CAPSULE in 1 BOTTLE (66267-132-18)Marketed from Oct 10, 2016 | |
| 66267-132-20 | 66267013220 | 20 CAPSULE in 1 BOTTLE (66267-132-20)Marketed from Oct 10, 2016 | |
| 66267-132-60 | 66267013260 | 15 CAPSULE in 1 BOTTLE (66267-132-60)Marketed from Dec 28, 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)
- Loperamide Hydrochloride
- Generic name (nonproprietary)
- loperamide hydrochloride
- Active ingredients
- Loperamide hydrochloride — 2 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073192
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 66267-132_1f93b346-5041-b800-e063-6294a90af72dSPL ID 1f93b346-5041-b800-e063-6294a90af72dSPL set ID 3e898141-8d40-49f1-e054-00144ff88e88RxCUI 978006UNII 77TI35393CUPC 0366267132152
- Pharmacologic class
- Opioid Agonist
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
N466267013212followed by a unit qualifier and the quantityPackage 66267-0132-12. 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 Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea and of chronic diarrhea associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 073192
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 |
|---|---|---|---|---|
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8747 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-973 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-0460 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Teva Pharmaceuticals USA, Inc. | 0093-0311 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 43063-020 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-2257 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-4699 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | American Health Packaging | 60687-229 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 55289-315 |