Over-the-counter drug · ANDA
Loperamide Hydrochloride NDC 46122-738
Loperamide hydrochloride 2 mg/1 · Tablet · Oral · Amerisource Bergen
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46122-738-53 | 46122073853 | 2 BLISTER PACK in 1 CARTON (46122-738-53) / 6 TABLET in 1 BLISTER PACKMarketed from Jul 5, 2023 | |
| 46122-738-62 | 46122073862 | 4 BLISTER PACK in 1 CARTON (46122-738-62) / 6 TABLET in 1 BLISTER PACKMarketed from Jul 20, 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)
- Loperamide Hydrochloride
- Generic name (nonproprietary)
- loperamide hydrochloride
- Active ingredients
- Loperamide hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amerisource Bergen
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206548
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 46122-738_c627fa26-44ac-4ba9-bc90-454a0ad98871SPL ID c627fa26-44ac-4ba9-bc90-454a0ad98871SPL set ID 6c15f077-9f90-4262-9c17-a1ac70e45f57RxCUI 978010UNII 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
N446122073853followed by a unit qualifier and the quantityPackage 46122-0738-53. 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 206548
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 | TabletOral | Aurobindo Pharma Limited | 84386-117 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | TabletOral | Aurohealth LLC | 58602-701 |
| Amazon Basic Care Loperamide Hydrochlorideloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | TabletOral | Amazon.com Services LLC | 72288-225 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | TabletOral | YYBA CORP | 73581-175 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8393 |
| Amazon Basic Care Loperamide Hydrochlorideloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | TabletOral | Proficient Rx LP | 82804-295 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | TabletOral | Aurohealth LLC | 58602-870 |