NDC 42571-169

DIPHENHYDRAMINE

Diphenhydramine Hydrochloride

DIPHENHYDRAMINE is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Micro Labs Limited. The primary component is Diphenhydramine Hydrochloride.

Product ID42571-169_7d59fa4b-36c3-1c52-e053-2a91aa0ac3df
NDC42571-169
Product TypeHuman Prescription Drug
Proprietary NameDIPHENHYDRAMINE
Generic NameDiphenhydramine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-12-04
Marketing CategoryANDA / ANDA
Application NumberANDA205723
Labeler NameMicro Labs Limited
Substance NameDIPHENHYDRAMINE HYDROCHLORIDE
Active Ingredient Strength50 mg/mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42571-169-55

10 AMPULE in 1 CARTON (42571-169-55) > 1 mL in 1 AMPULE (42571-169-54)
Marketing Start Date2018-12-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42571-169-55 [42571016955]

DIPHENHYDRAMINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205723
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-04

NDC 42571-169-54 [42571016954]

DIPHENHYDRAMINE INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205723
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-04

Drug Details

Active Ingredients

IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/mL

Pharmacological Class

  • Histamine H1 Receptor Antagonists [MoA]
  • Histamine-1 Receptor Antagonist [EPC]
  • Histamine H1 Receptor Antagonists [MoA]
  • Histamine-1 Receptor Antagonist [EPC]

NDC Crossover Matching brand name "DIPHENHYDRAMINE" or generic name "Diphenhydramine Hydrochloride"

NDCBrand NameGeneric Name
68196-929diphenhydraminediphenhydramine
76413-333DiphenhydramineDiphenhydramine
21695-500DiphenhydramineDiphenhydramine
21695-304DiphenhydramineDiphenhydramine
42571-169DIPHENHYDRAMINEDIPHENHYDRAMINE
51824-048DiphenhydramineDiphenhydramine
52959-053DiphenhydramineDiphenhydramine
57344-090DiphenhydramineDiphenhydramine
57344-113DiphenhydramineDiphenhydramine
58599-003DIPHENHYDRAMINEDIPHENHYDRAMINE
58599-004DIPHENHYDRAMINEDIPHENHYDRAMINE
63323-664DiphenhydramineDiphenhydramine
42571-337DIPHENHYDRAMINEDIPHENHYDRAMINE
61010-4409DiphenhydramineDiphenhydramine
0363-7100Adult Allergy ReliefDiphenhydramine Hydrochloride
0363-0100ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDE
0113-7479basic care allergy reliefDiphenhydramine Hydrochloride
0363-0710childrens Allergy Dye Free Wal DrylDiphenhydramine hydrochloride
0363-0004Childrens WAL-DRYLDiphenhydramine Hydrochloride
0121-0865Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
0121-1730Diphenhydramine HCl Oral Solutiondiphenhydramine hydrochloride
0121-0489DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
0121-0978DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDE
0185-0648diphenhydramine hydrochloridediphenhydramine hydrochloride
0185-0649diphenhydramine hydrochloridediphenhydramine hydrochloride
0363-0293Dye Free Wal Dryl AllergyDiphenhydramine Hydrochloride
0363-0753Dye Free Wal Sleep ZDIPHENHYDRAMINE HYDROCHLORIDE
0113-0462Good Sense Allergy Reliefdiphenhydramine hydrochloride
0113-0479good sense allergy reliefDiphenhydramine Hydrochloride
0113-0431good sense nighttime sleep aidDiphenhydramine Hydrochloride
0113-1909good sense sleep aiddiphenhydramine hydrochloride
0031-9304Robitussin Direct Runny Nosediphenhydramine
0363-0092Wal DrylDiphenhydramine Hydrochloride
0363-0379wal dryl allergyDiphenhydramine Hydrochloride
0363-0060Wal-Sleep ZDiphenhydramine Hydrochloride
0363-0223Wal-SomDiphenhydramine hydrochloride
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