Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
HF Acquisition Co LLC, DBA HealthFirst
045657305
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
HF Acquisition Co LLC, DBA HealthFirst
HF Acquisition Co LLC, DBA HealthFirst
HF Acquisition Co LLC, DBA HealthFirst
045657305
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DIPHENHYDRAMINE HCI
Product Details
NDC Product Code
51662-1218Application Number
ANDA040140Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAR, INTRAVENOUSEffective Date
February 19, 2020SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
DiphenhydramineActive
Code: TC2D6JAD40Class: ACTIBQuantity: 50 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT