FDA Product

NIZATIDINE

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

NIZATIDINE

FDA Product Code

60846-301

Regulatory Information

NDC Product Code

60846-301

Application Number

ANDA090576

Marketing Category

C73584

Effective Date

December 27, 2022

Territorial Authority

USA

FDA Title

Nizatidine Oral Solution 15 mg/mL Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

7

Company Information

ManufacturerAmneal Pharmaceuticals LLC

DUNS Number

123797875

Active Ingredients

Quantity: 15 mg in 1 mL

Code: P41PML4GHR

Class Code: ACTIB

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

SACCHARIN SODIUM

Code: SB8ZUX40TY

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

SODIUM CITRATE

Code: 1Q73Q2JULR

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

Active Moieties

NIZATIDINE

Code: P41PML4GHR

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