NDC 23635-416

EXALGO

Hydromorphone Hydrochloride

EXALGO is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Hydromorphone Hydrochloride.

• Product ID: 23635-416_0cc967c3-2f93-438b-a25c-0a4bbaf4f313
• NDC: 23635-416
• Product Type: Human Prescription Drug
• Proprietary Name: EXALGO
• Generic Name: Hydromorphone Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2010-03-01
• Marketing End Date: 2021-04-30
• Marketing Category: NDA / NDA
• Application Number: NDA021217
• Labeler Name: SpecGx LLC
• Substance Name: HYDROMORPHONE HYDROCHLORIDE
• Active Ingredient Strength: 16 mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N

Packaging

NDC 23635-416-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23635-416-01)

• Marketing Start Date: 2010-03-01
• Marketing End Date: 2021-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 23635-416-01 [23635041601]

EXALGO TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021217
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-03-01
• Marketing End Date: 2021-04-30

Drug Details

Active Ingredients

Ingredient	Strength
HYDROMORPHONE HYDROCHLORIDE	16 mg/1

OpenFDA Data

• SPL SET ID: 22e635cb-98c0-e4f9-6a71-62d7487a0a6c
• Manufacturer:
  • SpecGx LLC
• UNII:
  • L960UP2KRW
• RxNorm Concept Unique ID - RxCUI:
  • 1306900
  • 902738
  • 902729
  • 1306898
  • 902736
  • 902733
  • 902741
  • 902743
• UPC Code:
  • 0323635412018
  • 0323635408011
  • 0323635432016
  • 0323635416016

Pharmacological Class

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

Medicade Reported Pricing

23635041601 EXALGO ER 16 MG TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
23635-432	EXALGO	EXALGO
23635-416	EXALGO	EXALGO
23635-412	EXALGO	EXALGO
23635-408	EXALGO	EXALGO
0054-0264	Hydromorphone Hydrochloride	hydromorphone hydrochloride
0054-0265	Hydromorphone Hydrochloride	hydromorphone hydrochloride
0054-0386	Hydromorphone Hydrochloride	hydromorphone hydrochloride
0406-3243	Hydromorphone Hydrochloride	hydromorphone hydrochloride
0406-3244	Hydromorphone Hydrochloride	hydromorphone hydrochloride
0406-3249	Hydromorphone Hydrochloride	hydromorphone hydrochloride
0406-3308	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride
0406-3312	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride
0406-3316	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride
0406-3332	Hydromorphone Hydrochloride	Hydromorphone Hydrochloride
0409-1283	Hydromorphone Hydrochloride	HYDROMORPHONE HYDROCHLORIDE