NDC 13845-1200

SEROMYCIN

Cycloserine

SEROMYCIN is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Parsolex Gmp Center, Inc.. The primary component is Cycloserine.

• Product ID: 13845-1200_b67c1b1d-7687-427a-a07a-e8100c046f73
• NDC: 13845-1200
• Product Type: Human Prescription Drug
• Proprietary Name: SEROMYCIN
• Generic Name: Cycloserine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2009-03-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA060593
• Labeler Name: Parsolex Gmp Center, Inc.
• Substance Name: CYCLOSERINE
• Active Ingredient Strength: 250 mg/250mg
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 13845-1200-3

40 CAPSULE in 1 BOTTLE (13845-1200-3) > 250 mg in 1 CAPSULE (13845-1200-1)

• Marketing Start Date: 2009-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13845-1200-1 [13845120001]

SEROMYCIN CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA060593
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-03-01

NDC 13845-1200-3 [13845120003]

SEROMYCIN CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA060593
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2009-03-01

Drug Details

Active Ingredients

Ingredient	Strength
CYCLOSERINE	250 mg/250mg

OpenFDA Data

• SPL SET ID: e1e08327-4b90-463e-bb2a-22438cabcef2
• Manufacturer:
  • Purdue GMP Center LLC dba The Chao Center
• UNII:
  • 95IK5KI84Z
• RxNorm Concept Unique ID - RxCUI:
  • 197551
  • 212797
• UPC Code:
  • 0313845120032

NDC Crossover Matching brand name "SEROMYCIN" or generic name "Cycloserine"

NDC	Brand Name	Generic Name
13845-1200	SEROMYCIN	CYCLOSERINE
13845-1203	Seromycin	CycloSERINE
13845-1201	CYCLOSERINE	CYCLOSERINE
13845-1202	Cycloserine	Cycloserine
33342-462	Cycloserine	Cycloserine