Over-the-counter drug · ANDA
Loperamide Hydrochloride 2mg NDC 25000-001
loperamide hydrochloride tablets usp, 2mg · Loperamide hydrochloride 2 mg/1 · Tablet · Oral · MARKSANS PHARMA LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25000-001-83 | 2500000018325000000183 | 4 BLISTER PACK in 1 CARTON (25000-001-83) / 6 TABLET in 1 BLISTER PACKMarketed from Nov 19, 2025 |
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 2mg
- Generic name (nonproprietary)
- loperamide hydrochloride tablets usp, 2mg
- Active ingredients
- Loperamide hydrochloride — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- MARKSANS PHARMA LIMITEDNDC labeler code 25000
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220153
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 25000-001_2081729a-e6bb-44b8-8295-b7810b77df5eSPL ID 2081729a-e6bb-44b8-8295-b7810b77df5eSPL set ID 644fb37a-1d97-4333-a5c7-5a485ab338f7RxCUI 978010UNII 77TI35393CUPC 0325000001834
- 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
N425000000183followed by a unit qualifier and the quantityPackage 25000-0001-83. 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(S) Use controls symptoms of diarrhea, including Travelers' Diarrhea
Excerpt only. Read the full label for complete information.
About NDC 25000-001
- What is NDC 25000-001?
- 25000-001 is the product NDC for Loperamide Hydrochloride 2mg, Loperamide hydrochloride 2 mg/1 tablet, listed with the FDA by MARKSANS PHARMA LIMITED. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loperamide Hydrochloride 2mg (Loperamide Hydrochloride Tablets USP, 2mg).
- What is the active ingredient?
- Loperamide hydrochloride.
- Who is the labeler?
- MARKSANS PHARMA LIMITED, NDC labeler code 25000. 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 2mg?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 220153
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 |
|---|---|---|---|---|
| Anti-Diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Kroger | 41226-797 |