Over-the-counter drug · ANDA
Loperamide Hydrochloride (Loperamide hydrochloride oral) NDC 69452-405
Loperamide hydrochloride 1 mg/7.5mL · Solution · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-405-55 | 6945204055569452040555 | 120 mL in 1 BOTTLE (69452-405-55)Marketed from Mar 2, 2026 | |
| 69452-405-93 | 6945204059369452040593 | 240 mL in 1 BOTTLE (69452-405-93)Marketed from Mar 3, 2026 |
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 oral
- Active ingredients
- Loperamide hydrochloride — 1 mg/7.5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Bionpharma Inc.NDC labeler code 69452
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220100
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 69452-405_4bd07c07-575e-1543-e063-6294a90a9b3cSPL ID 4bd07c07-575e-1543-e063-6294a90a9b3cSPL set ID 4bd0939e-c172-d962-e063-6394a90a44b5RxCUI 1250685UNII 77TI35393CUPC 0369452405932, 0369452405550
- 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
N469452040555followed by a unit qualifier and the quantityPackage 69452-0405-55. 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.
About NDC 69452-405
- What is NDC 69452-405?
- 69452-405 is the product NDC for Loperamide Hydrochloride (loperamide hydrochloride oral), Loperamide hydrochloride 1 mg/7.5mL solution, listed with the FDA by Bionpharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loperamide Hydrochloride (Loperamide Hydrochloride oral).
- What is the active ingredient?
- Loperamide hydrochloride.
- Who is the labeler?
- Bionpharma Inc., NDC labeler code 69452. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Loperamide Hydrochloride?
- 74 other product NDCs are listed under this name. See all Loperamide Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loperamide Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | YYBA CORP | 73581-177 | 73581-0177-02 |
| Loperamide Hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Amazon.com Services LLC | 72288-048 | 72288-0048-34 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | TabletOral | YYBA CORP | 73581-175 | 73581-0175-24 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-0277 | 55154-0277-00 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 84386-117 | 84386-0117-24 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Coupler LLC | 67046-1676 | 67046-1676-03 |
| Loperamide Hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | DOLGENCORP INC | 55910-155 | 55910-0155-55 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Safecor Health LLC | 48433-063 | 48433-0063-20 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | TabletOral | Sportpharm LLC | 85766-154 | 85766-0154-0685766-0154-12 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | Aurohealth LLC | 58602-727 | 58602-0727-7458602-0727-7558602-0727-76+3 more |
Other NDCs under ANDA 220100
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 1 mg/7.5mL | SolutionOral | DOLGENCORP INC | 55910-155 |
| Loperamide Hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Kesin Pharma Corporation | 81033-067 |