IBUPROFEN AND DIPHENHYDRAMINE HCL

Product NDC
64380-732
11-digit product format
643800732
Labeler code
64380
Product ID
64380-732_2c462426-b635-44dd-b4cb-54f67afb37d9
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN AND DIPHENHYDRAMINE HCL
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA200888
Marketing category
ANDA
Marketing start
2012-03-05
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
Active strength
25 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-732-11643800732111 BOTTLE, PLASTIC in 1 CARTON (64380-732-11) > 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2016-12-280000-00-00NoNoCurrent
64380-732-12643800732121 BOTTLE, PLASTIC in 1 CARTON (64380-732-12) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2016-12-280000-00-00NoNoCurrent
64380-732-13643800732131 BOTTLE, PLASTIC in 1 CARTON (64380-732-13) > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2016-12-280000-00-00NoNoCurrent
64380-732-14643800732142 BLISTER PACK in 1 CARTON (64380-732-14) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2012-03-050000-00-00NoNoCurrent
64380-732-15643800732154 BLISTER PACK in 1 CARTON (64380-732-15) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2012-03-050000-00-00NoNoCurrent
64380-732-18643800732181 BOTTLE, PLASTIC in 1 CARTON (64380-732-18) > 180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2016-12-280000-00-00NoNoCurrent
64380-732-206438007322024 CARTON in 1 BOX (64380-732-20) > 24 BLISTER PACK in 1 CARTON (64380-732-19) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK24 carton2012-03-050000-00-00NoNoCurrent
64380-732-29643800732291 BOTTLE, PLASTIC in 1 CARTON (64380-732-29) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2016-12-280000-00-00NoNoCurrent
64380-732-92643800732923000 CAPSULE, LIQUID FILLED in 1 BAG (64380-732-92) 2021-11-300000-00-00NoNoCurrent