NDC 60687-258

Theophylline

Theophylline

Theophylline is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Theophylline Anhydrous.

• Product ID: 60687-258_6414f1d7-4cff-7504-e053-2991aa0a8972
• NDC: 60687-258
• Product Type: Human Prescription Drug
• Proprietary Name: Theophylline
• Generic Name: Theophylline
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2017-11-07
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091156
• Labeler Name: American Health Packaging
• Substance Name: THEOPHYLLINE ANHYDROUS
• Active Ingredient Strength: 80 mg/15mL
• Pharm Classes: Methylxanthine [EPC],Xanthines [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 60687-258-71

5 TRAY in 1 CASE (60687-258-71) > 10 CUP, UNIT-DOSE in 1 TRAY (60687-258-50) > 15 mL in 1 CUP, UNIT-DOSE (60687-258-44)

• Marketing Start Date: 2017-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 60687-258-44 [60687025844]

Theophylline SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091156
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-03-31

NDC 60687-258-71 [60687025871]

Theophylline SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091156
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-03-31

NDC 60687-258-50 [60687025850]

Theophylline SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091156
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-03-31

Drug Details

Active Ingredients

Ingredient	Strength
THEOPHYLLINE ANHYDROUS	80 mg/15mL

OpenFDA Data

• SPL SET ID: 9edb4123-28c7-42fe-8c4a-15244907b330
• Manufacturer:
  • American Health Packaging
• UNII:
  • 0I55128JYK
• RxNorm Concept Unique ID - RxCUI:
  • 313306

Pharmacological Class

• Methylxanthine [EPC]
• Xanthines [CS]

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

NDC	Brand Name	Generic Name
0121-0820	THEOPHYLLINE	THEOPHYLLINE
0121-4794	Theophylline	THEOPHYLLINE ANHYDROUS
0121-4820	THEOPHYLLINE	THEOPHYLLINE
0378-0486	Theophylline	Theophylline
0378-0487	Theophylline	Theophylline
0480-3309	Theophylline	Theophylline
0480-3310	Theophylline	Theophylline
10135-604	Theophylline	Theophylline Anhydrous
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
68151-1393	Theophylline	Theophylline
68462-380	Theophylline	Theophylline
68462-356	Theophylline	Theophylline
68788-0453	Theophylline	Theophylline
53808-0982	Theophylline	Theophylline
54838-556	Theophylline	Theophylline
60621-033	Theophylline	Theophylline
60687-258	Theophylline	Theophylline
62332-026	Theophylline	Theophylline
62332-025	Theophylline	Theophylline
63629-5198	Theophylline	Theophylline
63629-2792	Theophylline	Theophylline
16571-011	Theophylline(Anhydrous)	Theophylline