NDC 0615-1590

Theophylline Extended Release

Theophylline, Anhydrous

Theophylline Extended Release is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Theophylline.

• Product ID: 0615-1590_9864e22b-201f-455d-9361-786fad14bb2f
• NDC: 0615-1590
• Product Type: Human Prescription Drug
• Proprietary Name: Theophylline Extended Release
• Generic Name: Theophylline, Anhydrous
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 1990-04-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA089763
• Labeler Name: NCS HealthCare of KY, Inc dba Vangard Labs
• Substance Name: THEOPHYLLINE
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Methylxanthine [EPC],Xanthines [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 0615-1590-39

30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-1590-39)

• Marketing Start Date: 1990-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0615-1590-39 [00615159039]

Theophylline Extended Release TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA089763
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1990-04-30
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
THEOPHYLLINE	300 mg/1

OpenFDA Data

• SPL SET ID: 1750235a-ad52-4231-abe5-d3c441ba39e8
• Manufacturer:
  • NCS HealthCare of KY, Inc dba Vangard Labs
• UNII:
  • C137DTR5RG
• RxNorm Concept Unique ID - RxCUI:
  • 317769

Pharmacological Class

• Methylxanthine [EPC]
• Xanthines [CS]

NDC Crossover Matching brand name "Theophylline Extended Release" or generic name "Theophylline, Anhydrous"

NDC	Brand Name	Generic Name
0615-1590	Theophylline Extended Release	Theophylline, anhydrous
0615-2503	Theophylline Extended Release	Theophylline, anhydrous