NDC 55289-315

Loperamide Hydrochloride

Loperamide Hydrochloride

Loperamide Hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Loperamide Hydrochloride.

• Product ID: 55289-315_785d68bc-0b94-b69d-e053-2991aa0ac0d5
• NDC: 55289-315
• Product Type: Human Prescription Drug
• Proprietary Name: Loperamide Hydrochloride
• Generic Name: Loperamide Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1993-05-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA073192
• Labeler Name: PD-Rx Pharmaceuticals, Inc.
• Substance Name: LOPERAMIDE HYDROCHLORIDE
• Active Ingredient Strength: 2 mg/1
• Pharm Classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55289-315-06

6 CAPSULE in 1 BOTTLE, PLASTIC (55289-315-06)

• Marketing Start Date: 2011-09-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55289-315-30 [55289031530]

Loperamide Hydrochloride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA073192
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-09-23

NDC 55289-315-20 [55289031520]

Loperamide Hydrochloride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA073192
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-09-23

NDC 55289-315-12 [55289031512]

Loperamide Hydrochloride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA073192
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-09-23

NDC 55289-315-06 [55289031506]

Loperamide Hydrochloride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA073192
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-09-23

NDC 55289-315-15 [55289031515]

Loperamide Hydrochloride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA073192
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-09-23

NDC 55289-315-10 [55289031510]

Loperamide Hydrochloride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA073192
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-09-23

NDC 55289-315-08 [55289031508]

Loperamide Hydrochloride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA073192
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-09-23

Drug Details

Active Ingredients

Ingredient	Strength
LOPERAMIDE HYDROCHLORIDE	2 mg/1

OpenFDA Data

• SPL SET ID: 3310a3c2-389a-4b27-a478-67c905789854
• Manufacturer:
  • PD-Rx Pharmaceuticals, Inc.
• UNII:
  • 77TI35393C
• RxNorm Concept Unique ID - RxCUI:
  • 978006
• UPC Code:
  • 0355289315124

Pharmacological Class

• Opioid Agonist [EPC]
• Opioid Agonists [MoA]

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