NDC 53808-0316

Theophylline (Anhydrous)

Theophylline

Theophylline (Anhydrous) is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Theophylline Anhydrous.

• Product ID: 53808-0316_adfc71f3-28e7-4f69-95bd-2f87e3c0243d
• NDC: 53808-0316
• Product Type: Human Prescription Drug
• Proprietary Name: Theophylline (Anhydrous)
• Generic Name: Theophylline
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA089763
• Labeler Name: State of Florida DOH Central Pharmacy
• Substance Name: THEOPHYLLINE ANHYDROUS
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Methylxanthine [EPC],Xanthines [CS]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 53808-0316-1

30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (53808-0316-1)

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-0316-1 [53808031601]

Theophylline (Anhydrous) TABLET, EXTENDED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA089763
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
THEOPHYLLINE ANHYDROUS	300 mg/1

OpenFDA Data

• SPL SET ID: fc61fd7e-63ca-4714-851f-31b2a045903d
• Manufacturer:
  • State of Florida DOH Central Pharmacy
• UNII:
  • 0I55128JYK
• RxNorm Concept Unique ID - RxCUI:
  • 346574
  • 317769
• UPC Code:
  • 0350111459038
  • 0350111482012

Pharmacological Class

• Methylxanthine [EPC]
• Xanthines [CS]

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

NDC	Brand Name	Generic Name
68151-4210	Theophylline (Anhydrous)	Theophylline (Anhydrous)
53808-0316	Theophylline (Anhydrous)	Theophylline (Anhydrous)
53808-0315	Theophylline (Anhydrous)	Theophylline (Anhydrous)
51407-319	Theophylline (Anhydrous)	Theophylline (Anhydrous)
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
16571-011	Theophylline(Anhydrous)	Theophylline