NDC 53666-408

TABCIN 500

Acetylsalicylic Acid, Phenylephrine Bitartrate, Chlorpheniramine Maleate

TABCIN 500 is a Oral Tablet, Effervescent in the Human Otc Drug category. It is labeled and distributed by Salimex, S.a.. The primary component is Aspirin; Phenylephrine Bitartrate; Chlorpheniramine Maleate.

• Product ID: 53666-408_b09519e5-436d-4e8d-9183-fa3d17a09dc1
• NDC: 53666-408
• Product Type: Human Otc Drug
• Proprietary Name: TABCIN 500
• Generic Name: Acetylsalicylic Acid, Phenylephrine Bitartrate, Chlorpheniramine Maleate
• Dosage Form: Tablet, Effervescent
• Route of Administration: ORAL
• Marketing Start Date: 2013-08-21
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Salimex, S.A.
• Substance Name: ASPIRIN; PHENYLEPHRINE BITARTRATE; CHLORPHENIRAMINE MALEATE
• Active Ingredient Strength: 500 mg/1; mg/1; mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 53666-408-15

150 BOX in 1 CASE (53666-408-15) > 12 TABLET, EFFERVESCENT in 1 BOX (53666-408-12)

• Marketing Start Date: 2013-08-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53666-408-15 [53666040815]

TABCIN 500 TABLET, EFFERVESCENT

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-08-21
• Inactivation Date: 2020-01-31

NDC 53666-408-12 [53666040812]

TABCIN 500 TABLET, EFFERVESCENT

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-08-21

Drug Details

Active Ingredients

Ingredient	Strength
ASPIRIN	500 mg/1

OpenFDA Data

• SPL SET ID: 0039fee5-35a8-429b-a1cf-7b4bf1f8a6e7
• Manufacturer:
  • Salimex, S.A.
• UNII:
  • 27O3Q5ML57
  • V1Q0O9OJ9Z
  • R16CO5Y76E
• RxNorm Concept Unique ID - RxCUI:
  • 1536993
• Pharm Class PE:
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
• NUI Code:
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722

NDC Crossover Matching brand name "TABCIN 500" or generic name "Acetylsalicylic Acid, Phenylephrine Bitartrate, Chlorpheniramine Maleate"

NDC	Brand Name	Generic Name
53666-444	TABCIN 500	TABCIN 500
53666-408	TABCIN	Acetylsalicylic Acid, Phenylephrine Bitartrate, Chlorpheniramine maleate