NDC 0832-1054

Baclofen

Baclofen

Baclofen is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Llc. The primary component is Baclofen.

• Product ID: 0832-1054_317cc244-4ef2-4356-9fb6-4cb7ea467867
• NDC: 0832-1054
• Product Type: Human Prescription Drug
• Proprietary Name: Baclofen
• Generic Name: Baclofen
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2010-10-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074584
• Labeler Name: Upsher-Smith Laboratories, LLC
• Substance Name: BACLOFEN
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0832-1054-10

1000 TABLET in 1 BOTTLE (0832-1054-10)

• Marketing Start Date: 2018-02-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0832-1054-15 [00832105415]

Baclofen TABLET

• Marketing Category: ANDA
• Application Number: ANDA074584
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-02-27

NDC 0832-1054-90 [00832105490]

Baclofen TABLET

• Marketing Category: ANDA
• Application Number: ANDA074584
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-02-27

NDC 0832-1054-11 [00832105411]

Baclofen TABLET

• Marketing Category: ANDA
• Application Number: ANDA074584
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-02-27

NDC 0832-1054-10 [00832105410]

Baclofen TABLET

• Marketing Category: ANDA
• Application Number: ANDA074584
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-02-27

Drug Details

Active Ingredients

Ingredient	Strength
BACLOFEN	10 mg/1

OpenFDA Data

• SPL SET ID: b2747a9d-5fca-4657-9e4b-4112607f30d8
• Manufacturer:
  • Upsher-Smith Laboratories, LLC
• UNII:
  • H789N3FKE8
• RxNorm Concept Unique ID - RxCUI:
  • 197391
  • 197392
• UPC Code:
  • 0308321054901
  • 0308321055908

Pharmacological Class

• GABA A Agonists [MoA]
• GABA B Agonists [MoA]
• gamma-Aminobutyric Acid-ergic Agonist [EPC]

NDC Crossover Matching brand name "Baclofen" or generic name "Baclofen"

NDC	Brand Name	Generic Name
0115-1010	Baclofen	Baclofen
0115-1011	Baclofen	Baclofen
0115-1012	Baclofen	Baclofen
0172-4096	Baclofen	Baclofen
0172-4097	Baclofen	Baclofen
0527-1330	Baclofen	baclofen
0527-1333	Baclofen	baclofen
0527-1337	Baclofen	baclofen
0603-2406	Baclofen	Baclofen
0603-2407	Baclofen	Baclofen
0615-3541	Baclofen	Baclofen
0615-3542	Baclofen	Baclofen
0615-8411	Baclofen	Baclofen
0615-8412	Baclofen	Baclofen
68071-3075	Baclofen	Baclofen
68071-3001	Baclofen	Baclofen
68084-855	Baclofen	Baclofen
68084-868	Baclofen	Baclofen
68788-0522	Baclofen	Baclofen
68788-6903	Baclofen	Baclofen
68788-9246	Baclofen	Baclofen
68788-6384	Baclofen	Baclofen
68788-9735	Baclofen	Baclofen
68788-9796	Baclofen	Baclofen
68788-9846	Baclofen	Baclofen
70518-0215	Baclofen	Baclofen
70518-0362	Baclofen	Baclofen
70518-0411	Baclofen	Baclofen
70518-0547	Baclofen	Baclofen
70518-1515	Baclofen	Baclofen
70710-1285	Baclofen	Baclofen
70771-1449	Baclofen	Baclofen
70771-1448	Baclofen	Baclofen
70710-1286	Baclofen	Baclofen
71335-0206	Baclofen	Baclofen
71335-0344	Baclofen	Baclofen
71335-0103	Baclofen	Baclofen
71335-0949	BACLOFEN	BACLOFEN
0832-1025	Baclofen	Baclofen
0832-1055	Baclofen	Baclofen
0832-1024	Baclofen	Baclofen
0832-1054	Baclofen	Baclofen
0904-5222	Baclofen	Baclofen
0904-3365	Baclofen	Baclofen
0904-6476	Baclofen	Baclofen
0904-6475	Baclofen	Baclofen
10135-533	Baclofen	Baclofen
10135-532	Baclofen	Baclofen
10544-172	Baclofen	Baclofen
16714-072	Baclofen	Baclofen