Over-the-counter drug · ANDA
Loperamide Hydrochloride NDC 59556-959
Loperamide hydrochloride 2 mg/1 · Capsule, Liquid filled · Oral · Strides Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59556-959-05 | 59556095905 | 2 BLISTER PACK in 1 CARTON (59556-959-05) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (59556-959-03)Marketed from Oct 22, 2021 | |
| 59556-959-06 | 59556095906 | 1 BLISTER PACK in 1 CARTON (59556-959-06) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (59556-959-03)Marketed from Oct 22, 2021 |
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, Liquid filled
- Route
- Oral
- Labeler
- Strides Pharma, Inc.
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213070
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 59556-959_58ee3114-2863-e1e7-e063-6294a90a87c2SPL ID 58ee3114-2863-e1e7-e063-6294a90a87c2SPL set ID 4178b3cc-e1ca-4912-8b1f-eac0110a3940RxCUI 978006UNII 77TI35393C
- 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
N459556095905followed by a unit qualifier and the quantityPackage 59556-0959-05. 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)
Use controls symptoms of diarrhea, including Travelers' Diarrhea
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213070
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 | Capsule, Liquid filledOral | Dr. Reddy's Laboratories Inc. | 75907-097 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | Dr. Reddy's Laboratories Inc. | 43598-770 |