NDC 55315-165

Ibuprofen PM

Ibuprofen And Diphenhydramine Hcl

Ibuprofen PM is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Freds Inc. The primary component is Ibuprofen; Diphenhydramine Hydrochloride.

Product ID55315-165_77273084-e7ec-485e-83b8-227d22c17f81
NDC55315-165
Product TypeHuman Otc Drug
Proprietary NameIbuprofen PM
Generic NameIbuprofen And Diphenhydramine Hcl
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2011-06-10
Marketing End Date2019-12-31
Marketing CategoryANDA / ANDA
Application NumberANDA090397
Labeler NameFreds Inc
Substance NameIBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength200 mg/1; mg/1
NDC Exclude FlagN

Packaging

NDC 55315-165-16

2 BLISTER PACK in 1 CARTON (55315-165-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2011-06-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55315-165-16 [55315016516]

Ibuprofen PM CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA090397
Product TypeHUMAN OTC DRUG
Marketing Start Date2011-06-10
Marketing End Date2019-12-31

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:c0655afb-bd6e-4a5c-913f-7bd13538bf0f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 901814
  • PHarm Class EPC
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • NUI Code
  • N0000000160
  • N0000175722
  • N0000175721
  • NDC Crossover Matching brand name "Ibuprofen PM" or generic name "Ibuprofen And Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    0363-0050Ibuprofen PMdiphenhydramine citrate, ibuprofen
    0363-0207Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    0363-0250Ibuprofen PMIbuprofen, Diphenhydramine HCl
    0363-0611Ibuprofen PMDiphenhydramine hydrochloride, ibuprofen
    0363-0756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    11673-265Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    11673-756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    11822-0050ibuprofen pmDiphenhydramine Citrate, Ibuprofen
    30142-050ibuprofen pmdiphenhydramine citrate and ibuprofen
    30142-232Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    36800-165Ibuprofen PMIbuprofen and Diphenhydramine HCl
    36800-237Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    36800-756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    37012-050Ibuprofen PMdiphenhydramine citrate, ibuprofen
    37808-703ibuprofen pmdiphenhydramine citrate, ibuprofen
    41250-050Ibuprofen PMdiphenhydramine citrate, ibuprofen
    41250-285Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    41250-413ibuprofen pmDiphenhydramine citrate, Ibuprofen
    42507-050ibuprofen pmdiphenhydramine citrate, ibuprofen
    49035-670Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    50804-165Ibuprofen PMIbuprofen and Diphenhydramine HCl
    50844-611Ibuprofen PMDiphenhydramine hydrochloride, ibuprofen
    50844-732Ibuprofen PMIbuprofen and Diphenhydramine HCl
    55315-165Ibuprofen PMIbuprofen and Diphenhydramine HCl
    55319-050ibuprofen pmdiphenhydramine citrate, ibuprofen
    68016-057Ibuprofen PMIbuprofen PM
    69842-165Ibuprofen PMIbuprofen PM
    55910-565Ibuprofen PMIbuprofen PM
    55910-856Ibuprofen PMIbuprofen PM
    56062-050ibuprofen pmibuprofen pm
    59779-050ibuprofen pmibuprofen pm
    59779-413ibuprofen pmibuprofen pm
    0363-0413Ibuprofen PMIbuprofen PM
    63941-166Ibuprofen PMIbuprofen PM
    69842-656Ibuprofen PMIbuprofen PM
    69842-913Ibuprofen PMIbuprofen PM

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