Over-the-counter drug · ANDA
anti diarrheal (Loperamide hcl) NDC 37808-449
Loperamide hydrochloride 1 mg/7.5mL · Solution · Oral · H E B
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 37808-449-34 | 3780804493437808044934 | 240 mL in 1 BOTTLE (37808-449-34)Marketed from Jun 22, 2018 |
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)
- anti diarrheal
- Generic name (nonproprietary)
- loperamide hcl
- Active ingredients
- Loperamide hydrochloride — 1 mg/7.5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- H E BNDC labeler code 37808
- 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 37808-449_80acab10-ff9e-4353-8bf0-a9ea6138e047SPL ID 80acab10-ff9e-4353-8bf0-a9ea6138e047SPL set ID 01964f8a-f05c-4f72-9530-e0cffd981ffaRxCUI 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
N437808044934followed by a unit qualifier and the quantityPackage 37808-0449-34. 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)
Use controls symptoms of diarrhea, including Travelers’ Diarrhea
Excerpt only. Read the full label for complete information.
About NDC 37808-449
- What is NDC 37808-449?
- 37808-449 is the product NDC for anti diarrheal (loperamide hcl), Loperamide hydrochloride 1 mg/7.5mL solution, listed with the FDA by H E B. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- anti diarrheal (Loperamide HCl).
- What is the active ingredient?
- Loperamide hydrochloride.
- Who is the labeler?
- H E B, NDC labeler code 37808. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for anti diarrheal?
- 73 other product NDCs are listed under this name. See all anti diarrheal NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other anti diarrheal products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Anti-Diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Kroger | 41226-797 | 41226-0797-2241226-0797-24 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, CoatedOral | Grocery Outlet | 85828-248 | 85828-0248-93 |
| Anti-Diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | CHAIN DRUG MARKETING ASSOCIATION INC. | 83324-208 | 83324-0208-12 |
| Anti-Diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | CHAIN DRUG MARKETING ASSOCIATION INC. | 83324-209 | 83324-0209-24 |
| anti-diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | Albertsons Companies | 21130-835 | 21130-0835-12 |
| Anti-Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Advanced Rx LLC | 80513-375 | 80513-0375-08 |
| anti-diarrhealloperamide hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Safeway | 21130-381 | 21130-0381-34 |
| anti-diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Capsule, Liquid filledOral | PUBLIX SUPER MARKETS INC | 56062-680 | 56062-0680-12 |
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Chain Drug Marketing Association, Inc. | 83324-064 | 83324-0064-1283324-0064-24 |
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | TabletOral | Yyba Corp | 73581-171 | 73581-0171-24 |
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 |
| DG Health Anti Diarrhealloperamide hcl | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Dolgencorp Inc | 55910-867 |
| Loperamide Hydrochloride | Loperamide hydrochloride 1 mg/7.5mL | SolutionOral | Precision Dose, Inc. | 68094-129 |
| 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 |
Showing 20 of 28.