Prescription drug · ANDA
Loperamide Hydrochloride NDC 68071-3618
Loperamide hydrochloride 2 mg/1 · Capsule · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3618-1 | 6807136180168071361801 | 12 CAPSULE in 1 BOTTLE (68071-3618-1)Marketed from Jun 14, 2024 | |
| 68071-3618-2 | 6807136180268071361802 | 20 CAPSULE in 1 BOTTLE (68071-3618-2)Marketed from Jun 14, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 2 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- 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 68071-3618_200c6126-b08d-7aa4-e063-6394a90ab9dbSPL ID 200c6126-b08d-7aa4-e063-6394a90ab9dbSPL set ID 1adb7a28-9dc6-3f8b-e063-6394a90a9335RxCUI 978006UNII 77TI35393CUPC 0368071361810
- 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
N468071361801followed by a unit qualifier and the quantityPackage 68071-3618-01. 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)
INDICATIONS AND USAGE 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 68071-3618
- What is NDC 68071-3618?
- 68071-3618 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 capsule, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 2 package NDCs, 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?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 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 HCl | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Direct_Rx | 72189-686 |
| 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. | 68071-5331 |
| 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 |