NDC 68016-057

Ibuprofen PM

Ibuprofen, Diphenhydramine Hcl

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

Product ID68016-057_21afce91-afbe-4b38-a8a5-8775148835e8
NDC68016-057
Product TypeHuman Otc Drug
Proprietary NameIbuprofen PM
Generic NameIbuprofen, Diphenhydramine Hcl
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2018-10-25
Marketing CategoryANDA / ANDA
Application NumberANDA090397
Labeler NamePremier Value Alliance LLC
Substance NameIBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength200 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68016-057-40

1 BOTTLE in 1 CARTON (68016-057-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date2018-10-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68016-057-40 [68016005740]

Ibuprofen PM CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA090397
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-25

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:21afce91-afbe-4b38-a8a5-8775148835e8
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, 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
    68016-057Ibuprofen PMIbuprofen PM
    69842-165Ibuprofen PMIbuprofen PM
    50844-732Ibuprofen PMIbuprofen PM
    50804-165Ibuprofen PMIbuprofen PM
    50844-611Ibuprofen PMIbuprofen PM
    55315-165Ibuprofen PMIbuprofen PM
    55319-050ibuprofen 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
    0363-0665Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCL
    49035-065Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCL
    11673-225IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCL
    11822-0789IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCL
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