NDC 76045-121

Dilaudid

Hydromorphone Hydrochloride

Dilaudid is a Intramuscular; Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Hydromorphone Hydrochloride.

Product ID76045-121_5a28aca5-35d9-4e7b-b3e2-91c4611ee020
NDC76045-121
Product TypeHuman Prescription Drug
Proprietary NameDilaudid
Generic NameHydromorphone Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2016-12-16
Marketing CategoryNDA / NDA
Application NumberNDA019034
Labeler NameFresenius Kabi USA, LLC
Substance NameHYDROMORPHONE HYDROCHLORIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesFull Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 76045-121-11

10 SYRINGE in 1 CARTON (76045-121-11) > 1 mL in 1 SYRINGE (76045-121-01)
Marketing Start Date2020-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76045-121-11 [76045012111]

Dilaudid INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-16

NDC 76045-121-01 [76045012101]

Dilaudid INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-12-16

Drug Details

Active Ingredients

IngredientStrength
HYDROMORPHONE HYDROCHLORIDE.2 mg/mL

Pharmacological Class

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

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

NDCBrand NameGeneric Name
70399-102DILAUDIDDILAUDID
76045-009DilaudidDilaudid
76045-010DilaudidDilaudid
42858-122DilaudidDilaudid
42858-416DilaudidDilaudid
42858-338DilaudidDilaudid
42858-234DilaudidDilaudid
55154-1610DilaudidDilaudid
59011-442DILAUDIDDILAUDID
59011-444DILAUDIDDILAUDID
59011-452DILAUDIDDILAUDID
59011-458DILAUDIDDILAUDID
59011-451DILAUDIDDILAUDID
59011-454DILAUDIDDILAUDID
65084-440DILAUDIDDILAUDID
76045-121DilaudidDilaudid
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

Trademark Results [Dilaudid]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DILAUDID
DILAUDID
71327970 0298197 Live/Registered
E. BILHUBER, INC.
1932-06-14
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