NDC 0472-1030

Hydromet

Hydrocodone Bitartrate And Homatropine Methylbromide

Hydromet is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Homatropine Methylbromide; Hydrocodone Bitartrate.

• Product ID: 0472-1030_13833a04-8f2d-4ac7-bc72-b661457fec56
• NDC: 0472-1030
• Product Type: Human Prescription Drug
• Proprietary Name: Hydromet
• Generic Name: Hydrocodone Bitartrate And Homatropine Methylbromide
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2002-09-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA088017
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
• Active Ingredient Strength: 2 mg/5mL; mg/5mL
• Pharm Classes: Opioid Agonist [EPC], Opioid Agonists [MoA]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0472-1030-16

473 mL in 1 BOTTLE (0472-1030-16)

• Marketing Start Date: 2002-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0472-1030-16 [00472103016]

Hydromet SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA088017
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2002-09-30

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCODONE BITARTRATE	5 mg/5mL

OpenFDA Data

• SPL SET ID: a324c912-a3ef-4296-b9a8-b0fec687eb06
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • 68JRS2HC1C
  • NO70W886KK
• RxNorm Concept Unique ID - RxCUI:
  • 992675
  • 992668
• UPC Code:
  • 0304721030163

Pharmacological Class

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

NDC Crossover Matching brand name "Hydromet" or generic name "Hydrocodone Bitartrate And Homatropine Methylbromide"

NDC	Brand Name	Generic Name
0472-1030	Hydromet	hydrocodone bitartrate and homatropine methylbromide
64950-205	Hycodan	Hydrocodone Bitartrate and Homatropine Methylbromide
64950-342	Hycodan	Hydrocodone Bitartrate and Homatropine Methylbromide
0121-4811	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide
10702-055	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide
13668-577	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
17856-0043	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide
17856-0455	Hydrocodone Bitartrate and Homatropine Methylbromide	hydrocodone bitartrate and homatropine methylbromide
21695-869	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide
40032-118	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide
40032-810	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide
43386-118	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide
50383-043	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide
59741-262	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
60432-455	Hydrocodone Bitartrate and Homatropine Methylbromide	hydrocodone bitartrate and homatropine methylbromide
60687-278	Hydrocodone Bitartrate and Homatropine Methylbromide	hydrocodone bitartrate and homatropine methylbromide
64950-206	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide
64950-371	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide
66336-871	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide