Prescription drug · ANDA
Loperamide HCl NDC 72189-686
Loperamide hydrochloride 2 mg/1 · Capsule · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-686-20 | 7218906862072189068620 | 20 CAPSULE in 1 BOTTLE (72189-686-20)Marketed from Aug 25, 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 HCl
- Generic name (nonproprietary)
- loperamide hcl
- Active ingredients
- Loperamide hydrochloride — 2 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Direct_RxNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218122
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72189-686_59e1c4cf-17cd-13c9-e063-6294a90af61cSPL ID 59e1c4cf-17cd-13c9-e063-6294a90af61cSPL set ID 59e1c4cf-17cc-13c9-e063-6294a90af61cRxCUI 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
N472189068620followed by a unit qualifier and the quantityPackage 72189-0686-20. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Loperamide hydrochloride capsules are indicated for the control and symptomatic relief of acute nonspecific diarrhea in patients 2 years of age and older and of chronic diarrhea in adults associated with inflammatory bowel disease. Loperamide hydrochloride capsules are also indicated for reducing the volume of discharge from ileostomies.
Excerpt only. Read the full label for complete information.
About NDC 72189-686
- What is NDC 72189-686?
- 72189-686 is the product NDC for Loperamide HCl, Loperamide hydrochloride 2 mg/1 capsule, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Loperamide HCl.
- What is the active ingredient?
- Loperamide hydrochloride.
- Who is the labeler?
- Direct_Rx, NDC labeler code 72189. 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 HCl?
- 1 other product NDC are listed under this name. See all Loperamide HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Loperamide HCl 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 HCl | Loperamide hydrochloride 2 mg/1 | TabletOral | L.N.K. International, Inc. | 50844-735 | 50844-0735-0250844-0735-0850844-0735-19+4 more |
Other NDCs under ANDA 218122
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 | CapsuleOral | Major Pharmaceuticals | 0904-7472 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7398 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-691 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Coupler LLC | 67046-1676 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Redpharm Drug | 67296-2172 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-3618 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5331 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4283 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2571 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | NorthStar Rx LLC | 72603-328 |