NDC 21695-869

Hydrocodone Bitartrate and Homatropine Methylbromide

Hydrocodone Bitartrate And Homatropine Methylbromide

Hydrocodone Bitartrate and Homatropine Methylbromide is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Hydrocodone Bitartrate; Homatropine Methylbromide.

• Product ID: 21695-869_95828fad-323e-4510-acbf-6d354b25b887
• NDC: 21695-869
• Product Type: Human Prescription Drug
• Proprietary Name: Hydrocodone Bitartrate and Homatropine Methylbromide
• Generic Name: Hydrocodone Bitartrate And Homatropine Methylbromide
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2008-02-08
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040613
• Labeler Name: Rebel Distributors Corp
• Substance Name: HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
• Active Ingredient Strength: 5 mg/5mL; mg/5mL
• Pharm Classes: Opioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-869-16

473 mL in 1 BOTTLE (21695-869-16)

• Marketing Start Date: 2008-02-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-869-16 [21695086916]

Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP

• Marketing Category: ANDA
• Application Number: ANDA040613
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2008-02-08
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCODONE BITARTRATE	5 mg/5mL

OpenFDA Data

• SPL SET ID: 95828fad-323e-4510-acbf-6d354b25b887
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • 68JRS2HC1C
  • NO70W886KK
• RxNorm Concept Unique ID - RxCUI:
  • 992668

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0121-4811	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide
0574-1105	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone bitartrate, homatropine methylbromide
10702-055	Hydrocodone Bitartrate and Homatropine Methylbromide	Hydrocodone Bitartrate and Homatropine Methylbromide
10702-150	Hydrocodone Bitartrate and Homatropine Methylbromide	hydrocodone bitartrate and homatropine methylbromide oral solution
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
64950-205	Hycodan	Hydrocodone Bitartrate and Homatropine Methylbromide
64950-342	Hycodan	Hydrocodone Bitartrate and Homatropine Methylbromide
0472-1030	Hydromet	hydrocodone bitartrate and homatropine methylbromide