Nitrofurantoin (macrocrystals)

Product NDC

0378-1650

11-digit product format

003781650

Labeler code

0378

Product ID

0378-1650_808bdd29-3806-4d9d-8701-9a898ef9a916

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

nitrofurantoin (macrocrystals)

Dosage form

CAPSULE

Route

ORAL

Labeler

Mylan Pharmaceuticals Inc.

Application

ANDA074967

Marketing category

ANDA

Marketing start

1997-09-09

Marketing end

2019-08-31

Substance

NITROFURANTOIN

Active strength

50 mg/1

Pharmacologic classes

Nitrofurans [CS],Nitrofuran Antibacterial [EPC]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record