NDC 69452-205

IBUPROFEN, DIPHENHYDRAMINE HCL

Ibuprofen, Diphenhydramine Hcl

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

Product ID69452-205_0f6b5911-edb2-4e3a-b121-45c609b4c60e
NDC69452-205
Product TypeHuman Otc Drug
Proprietary NameIBUPROFEN, DIPHENHYDRAMINE HCL
Generic NameIbuprofen, Diphenhydramine Hcl
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2018-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA090397
Labeler NameBionpharma Inc.
Substance NameIBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength200 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69452-205-04

1 BLISTER PACK in 1 CARTON (69452-205-04) > 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69452-205-15 [69452020515]

IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA090397
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

NDC 69452-205-78 [69452020578]

IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA090397
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

NDC 69452-205-04 [69452020504]

IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA090397
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

NDC 69452-205-20 [69452020520]

IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA090397
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

NDC 69452-205-11 [69452020511]

IBUPROFEN, DIPHENHYDRAMINE HCL CAPSULE, LIQUID FILLED
Marketing CategoryANDA
Application NumberANDA090397
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN200 mg/1

OpenFDA Data

SPL SET ID:59a97c31-db90-48e1-ac1b-0f7026c8ec94
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, DIPHENHYDRAMINE HCL" or generic name "Ibuprofen, Diphenhydramine Hcl"

    NDCBrand NameGeneric Name
    11673-225IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCL
    11822-0789IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCL
    69452-205IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCL
    0363-0665Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCL
    49035-065Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCL
    49035-858Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCL
    59726-165Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCL
    68016-217Ibuprofen and Diphenhydramine HClIBUPROFEN, DIPHENHYDRAMINE HCL
    0363-0207Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    0363-0250Ibuprofen PMIbuprofen, Diphenhydramine HCl
    0363-0756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    11673-265Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    11673-756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    30142-232Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    36800-237Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    36800-756Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    41250-285Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    49035-670Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    55910-125Ibuprofen PMIbuprofen, Diphenhydramine HCL
    55910-565Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    55910-856Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    63868-829Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    68016-057Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCL
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.