Over-the-counter drug · ANDA
berkley and jensen anti diarrheal (Loperamide hydrochloride) NDC 68391-224
Loperamide hydrochloride 2 mg/1 · Tablet, Film coated · Oral · BJWC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68391-224-62 | 6839102246268391022462 | 24 BLISTER PACK in 1 CARTON (68391-224-62) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 15, 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)
- berkley and jensen anti diarrheal
- Generic name (nonproprietary)
- loperamide hydrochloride
- Active ingredients
- Loperamide hydrochloride — 2 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- BJWCNDC labeler code 68391
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075232
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 68391-224_16e8ebf2-bc1d-4930-9fd4-37258bfeaa6fSPL ID 16e8ebf2-bc1d-4930-9fd4-37258bfeaa6fSPL set ID dc29a8e9-f916-49d2-b9a6-d2b4537d7b58RxCUI 978010UNII 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
N468391022462followed by a unit qualifier and the quantityPackage 68391-0224-62. 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
Excerpt only. Read the full label for complete information.
About NDC 68391-224
- What is NDC 68391-224?
- 68391-224 is the product NDC for berkley and jensen anti diarrheal, Loperamide hydrochloride 2 mg/1 tablet, film coated, listed with the FDA by BJWC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- berkley and jensen anti diarrheal (Loperamide Hydrochloride).
- What is the active ingredient?
- Loperamide hydrochloride.
- Who is the labeler?
- BJWC, NDC labeler code 68391. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for berkley and jensen anti diarrheal?
- 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 075232
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 |
|---|---|---|---|---|
| Good Sense anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-0224 |
| Leader Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0225 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 59779-960 |
| basic care loperamide hydrochlorideloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-224 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Redpharm Drug Inc | 67296-1472 |
| CareOne Diarrhea Controlloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | American Sales Company | 41520-813 |
| dg health anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Dolgencorp, LLC | 55910-224 |
| Good Sense anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8750 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Meijer Distribution Inc | 41250-224 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7725 |
| Anti Diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | H E B | 37808-552 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-2224 |
| anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-1010 |
| Up and Up anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Target Corporation | 11673-224 |
| injoy diarrhea reliefloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | L. Perrigo Company | 0113-6004 |
| leader anti diarrhealloperamide hcl | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. dba Leader | 70000-0589 |
| topcare anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Topco Associates LLC | 36800-224 |
| Imodium A-Dloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-317 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | Publix Super Markets Inc | 56062-224 |
| anti diarrhealloperamide hydrochloride | Loperamide hydrochloride 2 mg/1 | Tablet, Film coatedOral | HyVee Inc | 42507-224 |
Showing 20 of 24.