NDC 0527-1873

Hydromorphone Hydrochloride

Hydromorphone Hydrochloride

Hydromorphone Hydrochloride is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Hydromorphone Hydrochloride.

Product ID0527-1873_66fed70b-7c83-410a-a955-42b3b4429f61
NDC0527-1873
Product TypeHuman Prescription Drug
Proprietary NameHydromorphone Hydrochloride
Generic NameHydromorphone Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2020-04-22
Marketing CategoryANDA / ANDA
Application NumberANDA207108
Labeler NameLannett Company, Inc.
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength5 mg/5mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0527-1873-47

473 mL in 1 BOTTLE (0527-1873-47)
Marketing Start Date2020-04-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-1873-47 [00527187347]

Hydromorphone Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA207108
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-22

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE5 mg/5mL

Pharmacological Class

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

NDC Crossover Matching brand name "Hydromorphone Hydrochloride" or generic name "Hydromorphone Hydrochloride"

NDCBrand NameGeneric Name
0054-0264Hydromorphone Hydrochloridehydromorphone hydrochloride
0054-0265Hydromorphone Hydrochloridehydromorphone hydrochloride
0054-0386Hydromorphone Hydrochloridehydromorphone hydrochloride
0406-3243Hydromorphone Hydrochloridehydromorphone hydrochloride
0406-3244Hydromorphone Hydrochloridehydromorphone hydrochloride
0406-3249Hydromorphone Hydrochloridehydromorphone hydrochloride
0406-3308Hydromorphone HydrochlorideHydromorphone Hydrochloride
0406-3312Hydromorphone HydrochlorideHydromorphone Hydrochloride
0406-3316Hydromorphone HydrochlorideHydromorphone Hydrochloride
0406-3332Hydromorphone HydrochlorideHydromorphone Hydrochloride
0409-1283Hydromorphone HydrochlorideHYDROMORPHONE HYDROCHLORIDE
0409-3459Hydromorphone HydrochlorideHydromorphone Hydrochloride
68084-472Hydromorphone HydrochlorideHydromorphone Hydrochloride
68084-423Hydromorphone HydrochlorideHydromorphone Hydrochloride
0527-1355Hydromorphone HydrochlorideHydromorphone Hydrochloride
0527-1353Hydromorphone HydrochlorideHydromorphone Hydrochloride
0527-1354Hydromorphone HydrochlorideHydromorphone Hydrochloride
0574-0293hydromorphone hydrochloridehydromorphone hydrochloride
0574-0295hydromorphone hydrochloridehydromorphone hydrochloride
0574-0294hydromorphone hydrochloridehydromorphone hydrochloride
0574-0297hydromorphone hydrochloridehydromorphone hydrochloride
70166-250Hydromorphone HydrochlorideHydromorphone Hydrochloride
0574-7224HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
0591-3631Hydromorphone HydrochlorideHydromorphone Hydrochloride
0591-3630Hydromorphone HydrochlorideHydromorphone Hydrochloride
0591-3629Hydromorphone HydrochlorideHydromorphone Hydrochloride
0591-3739Hydromorphone HydrochlorideHydromorphone Hydrochloride
71335-0229HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
71335-0265Hydromorphone HydrochlorideHydromorphone Hydrochloride
71335-0887HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
71335-0233Hydromorphone HydrochlorideHydromorphone Hydrochloride
71335-0723HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
71335-0303Hydromorphone HydrochlorideHydromorphone Hydrochloride
71335-0759Hydromorphone HydrochlorideHydromorphone Hydrochloride
0641-0121Hydromorphone HydrochlorideHydromorphone Hydrochloride
0641-6151Hydromorphone HydrochlorideHydromorphone Hydrochloride
0641-2341Hydromorphone HydrochlorideHydromorphone Hydrochloride
0703-0110Hydromorphone HydrochlorideHydromorphone Hydrochloride
0703-0018Hydromorphone HydrochlorideHydromorphone Hydrochloride
0703-0113Hydromorphone HydrochlorideHydromorphone Hydrochloride
13107-107HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
13107-109HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
13107-108HYDROMORPHONE HYDROCHLORIDEHYDROMORPHONE HYDROCHLORIDE
13811-701Hydromorphone HydrochlorideHydromorphone Hydrochloride
13811-703Hydromorphone HydrochlorideHydromorphone Hydrochloride
13811-702Hydromorphone HydrochlorideHydromorphone Hydrochloride
13811-704Hydromorphone HydrochlorideHydromorphone Hydrochloride
17478-540Hydromorphone HydrochlorideHydromorphone Hydrochloride
17856-0386Hydromorphone HydrochlorideHydromorphone Hydrochloride
35356-815Hydromorphone HydrochlorideHydromorphone Hydrochloride

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