Prescription drug · ANDA
Loperamide Hydrochloride NDC 60468-005
Loperamide hydrochloride 2 mg/1 · Capsule · Oral · allphamed Pharbil Arzneimittel GmbH
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60468-005-01 | 60468000501 | 100 CAPSULE in 1 BOTTLE (60468-005-01)Marketed from Sep 25, 2020 | |
| 60468-005-05 | 60468000505 | 500 CAPSULE in 1 BOTTLE (60468-005-05)Marketed from Sep 25, 2020 | |
| 60468-005-30 | 60468000530 | 30 CAPSULE in 1 BOTTLE (60468-005-30)Marketed from Sep 25, 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 — 2 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- allphamed Pharbil Arzneimittel GmbHNDC labeler code 60468
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215001
- Marketing start
- Listing expires
- Other FDA classes
- Opioid Agonists (Mechanism)
- Identifiers
- Product ID 60468-005_f54d6351-da06-808b-e053-2a95a90ae4cbSPL ID f54d6351-da06-808b-e053-2a95a90ae4cbSPL set ID a8c8d1d2-a8c7-462a-b620-729a9baa93c4RxCUI 978006UNII 77TI35393CUPC 0342799605036, 0342799605012, 0342799605029
- 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
N460468000501followed by a unit qualifier and the quantityPackage 60468-0005-01. 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 & USAGE Loperamide Hydrochloride Capsules (loperamide hydrochloride) is 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 is also indicated for reducing the volume of discharge from ileostomies.
Excerpt only. Read the full label for complete information.
About NDC 60468-005
- What is NDC 60468-005?
- 60468-005 is the product NDC for Loperamide Hydrochloride, Loperamide hydrochloride 2 mg/1 capsule, listed with the FDA by allphamed Pharbil Arzneimittel GmbH. It has 3 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?
- allphamed Pharbil Arzneimittel GmbH, NDC labeler code 60468. 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 215001
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 | Golden State Medical Supply, Inc. | 51407-999 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2111 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Edenbridge Pharmaceuticals LLC. | 42799-605 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-648 |
| Loperamide Hydrochloride | Loperamide hydrochloride 2 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-950 |