ZANTAC
(ranitidine) Injection Rx only
Approved
Approval ID
95dc4515-7690-4881-ae14-9f8655a68dfe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2020
Manufacturers
FDA
Teligent, Inc.
DUNS: 011036910
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ranitidine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52565-096
Application NumberNDA019090
Product Classification
M
Marketing Category
C73594
G
Generic Name
ranitidine hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMay 21, 2020
FDA Product Classification
INGREDIENTS (4)
RANITIDINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 mL
Code: BK76465IHM
Classification: ACTIM
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT