Over-the-counter drug · ANDA
Loperamide Hydrochloride NDC 68094-129
Loperamide hydrochloride 1 mg/7.5mL · Solution · Oral · Precision Dose, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68094-129-62 | 6809401296268094012962 | 3 TRAY in 1 CASE (68094-129-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (68094-129-59)Marketed from May 18, 2020 |
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
- Precision Dose, Inc.NDC labeler code 68094
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091292
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 68094-129_73a0214b-3f58-4357-ab53-314111602166SPL ID 73a0214b-3f58-4357-ab53-314111602166SPL set ID ae8237f0-95a6-4163-b476-25c0509ef151RxCUI 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
N468094012962followed by a unit qualifier and the quantityPackage 68094-0129-62. 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 Read complete directions and warnings before using.
Excerpt only. Read the full label for complete information.
About NDC 68094-129
- What is NDC 68094-129?
- 68094-129 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 1 mg/7.5mL solution, listed with the FDA by Precision Dose, Inc.. It has 1 package NDC, 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?
- Precision Dose, Inc., NDC labeler code 68094. 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 091292
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 |
|---|---|---|---|---|
| basic care loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Amazon.com Services LLC | 72288-645 |
| Loperamide Hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Amazon.com Services LLC | 72288-048 |
| loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Major Pharmaceuticals | 0904-6836 |
| Equate Loperamide Hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-451 |
| basic care loperamide hydrochlorideloperamide hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | Amazon.com Services LLC | 72288-758 |
| loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-6836 |
| loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Meijer Distribution Inc | 41250-813 |
| Loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | CVS Pharmacy | 69842-191 |
| loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-7842 |
| leader anti diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Cardinal Health 110, LLC. dba Leader | 70000-0417 |
| Loperamide Hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Precision Dose, Inc. | 68094-029 |
| leader anti diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | Cardinal Health 110, LLC. dba Leader | 70000-0418 |
| CareOne Diarrhea Controlloperamide hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | American Sales Company | 41520-841 |
| topcare loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Topco Associates LLC | 36800-583 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | H E B | 37808-449 |
| DG Health Anti Diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Dolgencorp Inc | 55910-867 |
| equaline loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | United Natural Foods, Inc. dba UNFI | 41163-210 |
| loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Rite Aid Corporation | 11822-5519 |
| equate diarrhea controlloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-695 |
| Good Sense antidiarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8796 |
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