NDC 0480-3310

Theophylline

Theophylline

Theophylline is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals, Inc.. The primary component is Theophylline.

Product ID0480-3310_f7ebf68c-3476-4368-b5d9-4bfd523f3c42
NDC0480-3310
Product TypeHuman Prescription Drug
Proprietary NameTheophylline
Generic NameTheophylline
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2022-10-31
Marketing CategoryANDA /
Application NumberANDA216961
Labeler NameTeva Pharmaceuticals, Inc.
Substance NameTHEOPHYLLINE
Active Ingredient Strength300 mg/1
Pharm ClassesMethylxanthine [EPC], Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0480-3310-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0480-3310-01)
Marketing Start Date2022-10-31
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Theophylline" or generic name "Theophylline"

NDCBrand NameGeneric Name
0121-0820THEOPHYLLINETHEOPHYLLINE
0121-4794TheophyllineTHEOPHYLLINE ANHYDROUS
0121-4820THEOPHYLLINETHEOPHYLLINE
0378-0486TheophyllineTheophylline
0378-0487TheophyllineTheophylline
0480-3309TheophyllineTheophylline
0480-3310TheophyllineTheophylline
10135-604TheophyllineTheophylline Anhydrous
17856-0038TheophyllineTheophylline
23155-741TheophyllineTheophylline
23155-742TheophyllineTheophylline
27808-033TheophyllineTheophylline
29033-001TheophyllineTheophylline
29033-002TheophyllineTheophylline
42858-701TheophyllineTheophylline
42858-702TheophyllineTheophylline
46708-025TheophyllineTheophylline
46708-026TheophyllineTheophylline
50111-459TheophyllineTheophylline
50111-482TheophyllineTheophylline
50111-483TheophyllineTheophylline
50111-518TheophyllineTheophylline
68151-1393TheophyllineTheophylline
68462-380TheophyllineTheophylline
68462-356TheophyllineTheophylline
68788-0453TheophyllineTheophylline
53808-0982TheophyllineTheophylline
54838-556TheophyllineTheophylline
60621-033TheophyllineTheophylline
60687-258TheophyllineTheophylline
62332-026TheophyllineTheophylline
62332-025TheophyllineTheophylline
63629-5198TheophyllineTheophylline
63629-2792TheophyllineTheophylline
16571-011Theophylline(Anhydrous)Theophylline

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.