NDC 68788-0453

Theophylline

Theophylline

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

Product ID68788-0453_e1708994-a146-43b2-90e8-07164e69af62
NDC68788-0453
Product TypeHuman Prescription Drug
Proprietary NameTheophylline
Generic NameTheophylline
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-08-20
Marketing CategoryANDA / ANDA
Application NumberANDA089808
Labeler NamePreferred Pharmaceuticals
Substance NameTHEOPHYLLINE AN
Active Ingredient Strength200 mg/1
Pharm ClassesMethylxanthine
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68788-0453-9

90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-0453-9)
Marketing Start Date2014-08-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-0453-9 [68788045309]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089808
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-20
Marketing End Date2019-04-04

NDC 68788-0453-6 [68788045306]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089808
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-20
Marketing End Date2019-04-04

NDC 68788-0453-3 [68788045303]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089808
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-20
Marketing End Date2019-04-04

NDC 68788-0453-1 [68788045301]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089808
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-20
Marketing End Date2019-04-04

NDC 68788-0453-2 [68788045302]

Theophylline TABLET, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA089808
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-08-20
Marketing End Date2019-04-04

Drug Details

Pharmacological Class

  • Methylxanthine [EPC]
  • Xanthines [CS]

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

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