Prescription drug · ANDA
Loperamide Hydrochloride NDC 55289-315
Loperamide hydrochloride 2 mg/1 · Capsule · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-315-06 | 55289031506 | 6 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-06)Marketed from Sep 23, 2011 | |
| 55289-315-08 | 55289031508 | 8 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-08)Marketed from Sep 23, 2011 | |
| 55289-315-10 | 55289031510 | 10 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-10)Marketed from Sep 23, 2011 | |
| 55289-315-12 | 55289031512 | 12 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-12)Marketed from Sep 23, 2011 | |
| 55289-315-15 | 55289031515 | 15 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-15)Marketed from Sep 23, 2011 | |
| 55289-315-20 | 55289031520 | 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-20)Marketed from Sep 23, 2011 | |
| 55289-315-30 | 55289031530 | 30 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-30)Marketed from Sep 23, 2011 |
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
- PD-Rx 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 55289-315_4199e187-f646-693a-e063-6294a90ae583SPL ID 4199e187-f646-693a-e063-6294a90ae583SPL set ID 3310a3c2-389a-4b27-a478-67c905789854RxCUI 978006UNII 77TI35393CUPC 0355289315155
- 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
N455289031506followed by a unit qualifier and the quantityPackage 55289-0315-06. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Loperamide hydrochloride is indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults 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 | NuCare Pharmaceuticals, Inc. | 66267-132 |
| 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 |