NDC 17856-0038

Theophylline

Theophylline

Theophylline is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corp.. The primary component is Theophylline Anhydrous.

Product ID17856-0038_0cbea6bb-8f70-446f-a80e-c971b916c0bc
NDC17856-0038
Product TypeHuman Prescription Drug
Proprietary NameTheophylline
Generic NameTheophylline
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2012-08-02
Marketing CategoryANDA / ANDA
Application NumberANDA091586
Labeler NameATLANTIC BIOLOGICALS CORP.
Substance NameTHEOPHYLLINE ANHYDROUS
Active Ingredient Strength80 mg/15mL
Pharm ClassesMethylxanthine [EPC],Xanthines [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 17856-0038-1

50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0038-1) > 15 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2021-01-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0038-1 [17856003801]

Theophylline SOLUTION
Marketing CategoryANDA
Application NumberANDA091586
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-11

Drug Details

Active Ingredients

IngredientStrength
THEOPHYLLINE ANHYDROUS80 mg/15mL

Pharmacological Class

  • Methylxanthine [EPC]
  • Xanthines [CS]
  • 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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