Promethazine Hydrochloride
Promethazine Hydrochloride Suppositories, USP25 mg
Approved
Approval ID
3087a1cb-fda5-4115-86b6-1cce480a2f8e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 11, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Promethazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-649
Application NumberANDA040500
Product Classification
M
Marketing Category
C73584
G
Generic Name
Promethazine Hydrochloride
Product Specifications
Route of AdministrationRECTAL
Effective DateJanuary 11, 2007
FDA Product Classification
INGREDIENTS (5)
Promethazine HydrochlorideActive
Quantity: 25 mg in 1 1
Code: R61ZEH7I1I
Classification: ACTIB
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
COCOA BUTTERInactive
Code: 512OYT1CRR
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT