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NDC 00037-6860-10 Dipentum 250 mg/1 Details

Dipentum 250 mg/1

Dipentum is a ORAL CAPSULE, GELATIN COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Meda Pharmaceuticals Inc.. The primary component is OLSALAZINE SODIUM.

MedlinePlus Drug Summary

Olsalazine is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults when another medication (sulfasalazine) could not be tolerated. Olsalazine is in a class of medications called anti-inflammatory agents. Olsalazine reduces the bowel inflammation, diarrhea (stool frequency), rectal bleeding, and abdominal pain.

Related Packages: 00037-6860-10
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Olsalazine

Product Information

NDC	00037-6860
Product ID	0037-6860_f463a4ea-ba23-47da-af7f-92c2d7367a82
Associated GPIs	52500040100120
GCN Sequence Number	015514
GCN Sequence Number Description	olsalazine sodium CAPSULE 250 MG ORAL
HIC3	D6F
HIC3 Description	DRUG TX-CHRONIC INFLAM. COLON DX,5-AMINOSALICYLAT
GCN	33401
HICL Sequence Number	005889
HICL Sequence Number Description	OLSALAZINE SODIUM
Brand/Generic	Brand
Proprietary Name	Dipentum
Proprietary Name Suffix	n/a
Non-Proprietary Name	olsalazine sodium
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	CAPSULE, GELATIN COATED
Route	ORAL
Active Ingredient Strength	250
Active Ingredient Units	mg/1
Substance Name	OLSALAZINE SODIUM
Labeler Name	Meda Pharmaceuticals Inc.
Pharmaceutical Class	Aminosalicylate [EPC], Aminosalicylic Acids [CS]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA019715
Listing Certified Through	2024-12-31

Package

NDC 00037-6860-10 (00037686010)

Pricing Information	N/A
NDC Package Code	0037-6860-10
Billing NDC	00037686010
Package	100 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (0037-6860-10)
Marketing Start Date	2015-05-15
NDC Exclude Flag	N