NDC 55758-310

Dolex Flex

Ibuprofen

Dolex Flex is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Pharmadel Llc. The primary component is Ibuprofen.

Product ID55758-310_822d9def-504d-9beb-e053-2991aa0a280e
NDC55758-310
Product TypeHuman Otc Drug
Proprietary NameDolex Flex
Generic NameIbuprofen
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2019-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA206999
Labeler NamePharmadel LLC
Substance NameIBUPROFEN
Active Ingredient Strength200 mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55758-310-20

1 BOTTLE in 1 CARTON (55758-310-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date2019-10-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55758-310-20 [55758031020]

Dolex Flex CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA206999
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

NDC Crossover Matching brand name "Dolex Flex" or generic name "Ibuprofen"

NDCBrand NameGeneric Name
55758-310Dolex FlexDolex Flex
0113-1461basic care childrens ibuprofenIbuprofen
0113-7619basic care childrens ibuprofenibuprofen
0113-7660basic care childrens ibuprofenIbuprofen
0113-7897Basic Care childrens ibuprofenIbuprofen
0113-0788Basic Care ibuprofenIbuprofen
0113-7131basic care ibuprofenIbuprofen
0113-7517basic care ibuprofenIbuprofen
0113-7604Basic Care IbuprofenIbuprofen
0121-0917Childrens IbuprofenIbuprofen
0121-0914Childrens Ibuprofen Oral SuspensionIbuprofen
0113-2461Good Sense Childrens IbuprofenIbuprofen
0113-0057Good Sense ibuprofenibuprofen
0113-0074Good Sense ibuprofenIbuprofen
0113-0166good sense ibuprofenIbuprofen
0113-0298good sense ibuprofenIbuprofen
0113-0461Good Sense ibuprofenIbuprofen
0113-0517Good Sense ibuprofenIbuprofen
0113-0604good sense ibuprofenIbuprofen
0113-0647good sense ibuprofenIbuprofen
0113-0660Good Sense IbuprofenIbuprofen
0113-0685Good Sense IbuprofenIbuprofen
0113-0897good sense ibuprofenIbuprofen
0113-1212Good Sense IbuprofenIbuprofen
0113-4501good sense ibuprofenibuprofen
0113-0040Good Sense Infants IbuprofenIbuprofen
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