NDC 50383-618

Loperamide Hydrochloride

Loperamide Hydrochloride

Loperamide Hydrochloride is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Loperamide Hydrochloride.

• Product ID: 50383-618_329e677e-d030-47e9-a589-67bd28b8e443
• NDC: 50383-618
• Product Type: Human Otc Drug
• Proprietary Name: Loperamide Hydrochloride
• Generic Name: Loperamide Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 1995-11-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074352
• Labeler Name: Hi-Tech Pharmacal Co., Inc.
• Substance Name: LOPERAMIDE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 50383-618-04

1 BOTTLE in 1 CARTON (50383-618-04) > 118 mL in 1 BOTTLE

• Marketing Start Date: 1995-11-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50383-618-04 [50383061804]

Loperamide Hydrochloride SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074352
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 1995-11-17

NDC 50383-618-11 [50383061811]

Loperamide Hydrochloride SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074352
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-02-27

NDC 50383-618-05 [50383061805]

Loperamide Hydrochloride SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074352
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-07-19

NDC 50383-618-06 [50383061806]

Loperamide Hydrochloride SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074352
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-02-27

NDC 50383-618-10 [50383061810]

Loperamide Hydrochloride SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074352
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2013-07-19

Drug Details

Active Ingredients

Ingredient	Strength
LOPERAMIDE HYDROCHLORIDE	1 mg/5mL

OpenFDA Data

• SPL SET ID: 3a624112-2903-43fb-9c6b-a9a4fc03da9c
• Manufacturer:
  • Hi-Tech Pharmacal Co., Inc.
• UNII:
  • 77TI35393C
• RxNorm Concept Unique ID - RxCUI:
  • 977986

Medicade Reported Pricing

50383061804 LOPERAMIDE 1 MG/5 ML LIQUID

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Loperamide Hydrochloride" or generic name "Loperamide Hydrochloride"

NDC	Brand Name	Generic Name
0093-0311	Loperamide Hydrochloride	Loperamide Hydrochloride
0113-7224	loperamide hydrochloride	Loperamide HCl
0363-0645	loperamide hydrochloride	loperamide HCl
0363-1645	loperamide hydrochloride	loperamide HCl
0378-2100	Loperamide Hydrochloride	loperamide hydrochloride
0615-0362	Loperamide Hydrochloride	loperamide hydrochloride
0615-8012	Loperamide Hydrochloride	Loperamide Hydrochloride
0615-8087	Loperamide Hydrochloride	loperamide hydrochloride
0904-6256	loperamide hydrochloride	loperamide HCl
0904-6836	loperamide hydrochloride	loperamide HCl
11822-1645	loperamide hydrochloride	loperamide HCl
11822-5519	loperamide hydrochloride	loperamide HCl
15127-338	Loperamide Hydrochloride	Loperamide Hydrochloride
17856-0618	Loperamide Hydrochloride	Loperamide Hydrochloride
68016-123	Loperamide Hydrochloride	Loperamide Hydrochloride
68071-4075	Loperamide Hydrochloride	Loperamide Hydrochloride
68094-108	Loperamide Hydrochloride	Loperamide Hydrochloride
68094-107	Loperamide Hydrochloride	Loperamide Hydrochloride
68151-0618	Loperamide Hydrochloride	Loperamide Hydrochloride
68788-9079	Loperamide Hydrochloride	Loperamide Hydrochloride
68788-9704	loperamide hydrochloride	loperamide hydrochloride
68788-9773	Loperamide Hydrochloride	Loperamide Hydrochloride
68998-123	Loperamide Hydrochloride	Loperamide Hydrochloride
69842-191	Loperamide hydrochloride	Loperamide hydrochloride
70518-0313	Loperamide Hydrochloride	Loperamide Hydrochloride
70518-0052	Loperamide Hydrochloride	Loperamide Hydrochloride
70518-0072	Loperamide Hydrochloride	Loperamide Hydrochloride
70518-0893	Loperamide Hydrochloride	Loperamide Hydrochloride
76413-314	Loperamide hydrochloride	Loperamide hydrochloride
21695-692	Loperamide Hydrochloride	Loperamide Hydrochloride
30142-645	Loperamide Hydrochloride	Loperamide Hydrochloride
33261-344	Loperamide Hydrochloride	Loperamide Hydrochloride
35418-123	Loperamide Hydrochloride	Loperamide Hydrochloride
37012-123	Loperamide Hydrochloride	Loperamide Hydrochloride
37808-645	Loperamide Hydrochloride	Loperamide Hydrochloride
41250-645	loperamide hydrochloride	loperamide hydrochloride
41250-813	loperamide hydrochloride	loperamide hydrochloride
42708-074	Loperamide Hydrochloride	Loperamide Hydrochloride
43063-431	Loperamide Hydrochloride	Loperamide Hydrochloride
43063-020	Loperamide Hydrochloride	Loperamide Hydrochloride
46122-169	Loperamide Hydrochloride	Loperamide Hydrochloride
50090-0461	Loperamide Hydrochloride	Loperamide Hydrochloride
50090-2859	Loperamide Hydrochloride	Loperamide Hydrochloride
50383-618	Loperamide Hydrochloride	Loperamide Hydrochloride
50436-3974	Loperamide Hydrochloride	Loperamide Hydrochloride
51079-690	Loperamide Hydrochloride	Loperamide Hydrochloride
51660-123	Loperamide Hydrochloride	Loperamide Hydrochloride
51655-547	Loperamide hydrochloride	Loperamide hydrochloride
53329-664	Loperamide Hydrochloride	Loperamide Hydrochloride
53808-0707	Loperamide Hydrochloride	Loperamide Hydrochloride