NDC 17478-450

Lortab

Hydrocodone Bitartrate And Acetaminophen

Lortab is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Akorn, Inc.. The primary component is Hydrocodone Bitartrate; Acetaminophen.

• Product ID: 17478-450_1ea462c1-6fff-4e75-9f8a-0df542be58b7
• NDC: 17478-450
• Product Type: Human Prescription Drug
• Proprietary Name: Lortab
• Generic Name: Hydrocodone Bitartrate And Acetaminophen
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2015-03-17
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040881
• Labeler Name: Akorn, Inc.
• Substance Name: HYDROCODONE BITARTRATE; ACETAMINOPHEN
• Active Ingredient Strength: 10 mg/15mL; mg/15mL
• Pharm Classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
• DEA Schedule: CII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 17478-450-16

473 mL in 1 BOTTLE, PLASTIC (17478-450-16)

• Marketing Start Date: 2015-03-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17478-450-16 [17478045016]

Lortab SYRUP

• Marketing Category: ANDA
• Application Number: ANDA040881
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-03-17

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCODONE BITARTRATE	10 mg/15mL

OpenFDA Data

• SPL SET ID: 21def91d-b6e3-4dde-983c-6925aedf0df0
• Manufacturer:
  • Akorn, Inc.
• UNII:
  • 362O9ITL9D
  • NO70W886KK
• RxNorm Concept Unique ID - RxCUI:
  • 1442445
  • 1044427
• UPC Code:
  • 0317478450160

Pharmacological Class

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

Medicade Reported Pricing

17478045016 LORTAB 10 MG-300 MG/15 ML ELXR

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Lortab" or generic name "Hydrocodone Bitartrate And Acetaminophen"

NDC	Brand Name	Generic Name
17856-0450	Lortab	Lortab
17478-450	Lortab	Lortab
0121-0772	Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE and ACETAMINOPHEN
0121-1544	Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE and ACETAMINOPHEN
0121-2316	Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE and ACETAMINOPHEN
0121-4772	Hydrocodone Bitartrate and Acetaminophen	HYDROCODONE BITARTRATE and ACETAMINOPHEN
0245-0410	Hydrocodone Bitartrate and Acetaminophen	Hydrocodone Bitartrate and Acetaminophen
0023-6002	Norco	Hydrocodone Bitartrate and Acetaminophen
0023-6021	Norco	Hydrocodone Bitartrate and Acetaminophen
0023-6022	Norco	Hydrocodone Bitartrate and Acetaminophen
0074-3041	Vicodin	Hydrocodone Bitartrate and Acetaminophen
0074-3043	Vicodin	Hydrocodone Bitartrate and Acetaminophen
0074-3054	Vicodin	Hydrocodone Bitartrate and Acetaminophen
0121-1542	Zamicet	HYDROCODONE BITARTRATE and ACETAMINOPHEN
0121-2313	Zamicet	HYDROCODONE BITARTRATE and ACETAMINOPHEN