NDC 0378-6333

Acamprosate Calcium

Acamprosate Calcium Enteric-coated

Acamprosate Calcium is a Oral Tablet, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Acamprosate Calcium.

• Product ID: 0378-6333_674a742a-1165-40e3-857c-9a25518d86fa
• NDC: 0378-6333
• Product Type: Human Prescription Drug
• Proprietary Name: Acamprosate Calcium
• Generic Name: Acamprosate Calcium Enteric-coated
• Dosage Form: Tablet, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2014-09-24
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200142
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: ACAMPROSATE CALCIUM
• Active Ingredient Strength: 333 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0378-6333-80

180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-6333-80)

• Marketing Start Date: 2014-09-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-6333-05 [00378633305]

Acamprosate Calcium TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA200142
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-09-24
• Marketing End Date: 2017-11-27

NDC 0378-6333-80 [00378633380]

Acamprosate Calcium TABLET, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA200142
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-09-24

Drug Details

Active Ingredients

Ingredient	Strength
ACAMPROSATE CALCIUM	333 mg/1

OpenFDA Data

• SPL SET ID: 75ddfd10-55b2-426e-bc74-3413cd0d7c94
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 59375N1D0U
• RxNorm Concept Unique ID - RxCUI:
  • 835726
• UPC Code:
  • 0303786333806

NDC Crossover Matching brand name "Acamprosate Calcium" or generic name "Acamprosate Calcium Enteric-coated"

NDC	Brand Name	Generic Name
0093-5352	Acamprosate Calcium	Acamprosate Calcium
0378-6333	Acamprosate Calcium	acamprosate calcium enteric-coated
0904-7213	Acamprosate Calcium	Acamprosate Calcium
10135-636	Acamprosate Calcium	Acamprosate Calcium
42291-104	Acamprosate Calcium	Acamprosate Calcium
51079-241	Acamprosate Calcium	acamprosate calcium enteric-coated
60687-121	Acamprosate Calcium	Acamprosate Calcium
68382-569	acamprosate calcium	acamprosate calcium
68462-435	Acamprosate Calcium	Acamprosate Calcium
70771-1057	acamprosate calcium	acamprosate calcium
68151-4760	Campral	acamprosate calcium