Over-the-counter drug · ANDA
Loperamide Hydrochloride NDC 81033-067
Loperamide hydrochloride 1 mg/7.5mL · Solution · Oral · Kesin Pharma Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81033-067-34 | 81033006734 | 30 CUP, UNIT-DOSE in 1 CARTON (81033-067-34) / 7.5 mL in 1 CUP, UNIT-DOSE (81033-067-07)Marketed from Jun 30, 2026 | |
| 81033-067-35 | 81033006735 | 30 CUP, UNIT-DOSE in 1 CARTON (81033-067-35) / 15 mL in 1 CUP, UNIT-DOSE (81033-067-15)Marketed from Jun 30, 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
- Active ingredients
- Loperamide hydrochloride — 1 mg/7.5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Kesin Pharma CorporationNDC labeler code 81033
- 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 81033-067_52e6ecd3-7e31-a74b-e063-6294a90ab15cSPL ID 52e6ecd3-7e31-a74b-e063-6294a90ab15cSPL set ID 52e6ecc5-5f3d-9989-e063-6294a90af2dcRxCUI 1250685UNII 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
N481033006734followed by a unit qualifier and the quantityPackage 81033-0067-34. 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)
Uses Controls symptoms of diarrhea, including Travelers' Diarrhea
Excerpt only. Read the full label for complete information.
About NDC 81033-067
- What is NDC 81033-067?
- 81033-067 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 1 mg/7.5mL solution, listed with the FDA by Kesin Pharma Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loperamide Hydrochloride.
- What is the active ingredient?
- Loperamide hydrochloride.
- Who is the labeler?
- Kesin Pharma Corporation, NDC labeler code 81033. 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 Hydrochlorideloperamide hydrochloride oral | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Bionpharma Inc. | 69452-405 | 69452-0405-5569452-0405-93 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | TabletOral | Sportpharm LLC | 85766-154 | 85766-0154-0685766-0154-12 |
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 Hydrochlorideloperamide hydrochloride oral | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Bionpharma Inc. | 69452-405 |
| Loperamide Hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | DOLGENCORP INC | 55910-155 |