NDC 16571-011

Theophylline(Anhydrous)

Theophylline

Theophylline(Anhydrous) is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Pack Pharmaceuticals, Llc. The primary component is Theophylline Anhydrous.

• Product ID: 16571-011_d3c75f8e-7b30-4536-862a-74e773853575
• NDC: 16571-011
• Product Type: Human Prescription Drug
• Proprietary Name: Theophylline(Anhydrous)
• Generic Name: Theophylline
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2010-09-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA040595
• Labeler Name: PACK Pharmaceuticals, LLC
• Substance Name: THEOPHYLLINE ANHYDROUS
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Methylxanthine [EPC],Xanthines [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 16571-011-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-011-01)

• Marketing Start Date: 2010-09-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 16571-011-01 [16571001101]

Theophylline(Anhydrous) TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA040595
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-09-15
• Marketing End Date: 2019-04-18
• Inactivation Date: 2019-10-21
• Reactivation Date: 2019-11-05

NDC 16571-011-10 [16571001110]

Theophylline(Anhydrous) TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA040595
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-09-15
• Marketing End Date: 2019-04-18

Drug Details

Active Ingredients

Ingredient	Strength
THEOPHYLLINE ANHYDROUS	400 mg/1

OpenFDA Data

• SPL SET ID: e118df30-a578-4cf0-93c8-689d15415ec2
• Manufacturer:
  • PACK Pharmaceuticals, LLC
• UNII:
  • 0I55128JYK
• RxNorm Concept Unique ID - RxCUI:
  • 313291
• UPC Code:
  • 0316571011100

Pharmacological Class

• Methylxanthine [EPC]
• Xanthines [CS]

Medicade Reported Pricing

16571001110 THEOPHYLLINE ER 400 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Theophylline(Anhydrous)" or generic name "Theophylline"

NDC	Brand Name	Generic Name
16571-011	Theophylline(Anhydrous)	Theophylline
0121-0820	THEOPHYLLINE	THEOPHYLLINE
0121-4820	THEOPHYLLINE	THEOPHYLLINE
0378-0486	Theophylline	Theophylline
0378-0487	Theophylline	Theophylline
0480-3309	Theophylline	Theophylline
0480-3310	Theophylline	Theophylline
17856-0038	Theophylline	Theophylline
23155-741	Theophylline	Theophylline
23155-742	Theophylline	Theophylline
27808-033	Theophylline	Theophylline
29033-001	Theophylline	Theophylline
29033-002	Theophylline	Theophylline
42858-701	Theophylline	Theophylline
42858-702	Theophylline	Theophylline
46708-025	Theophylline	Theophylline
46708-026	Theophylline	Theophylline
50111-459	Theophylline	Theophylline
50111-482	Theophylline	Theophylline
50111-483	Theophylline	Theophylline
50111-518	Theophylline	Theophylline
51407-318	Theophylline	Theophylline