NDC 0904-6580

Esomeprazole Magnesium

Esomeprazole Magnesium

Esomeprazole Magnesium is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Major Pharmaceuticals. The primary component is Esomeprazole Magnesium.

• Product ID: 0904-6580_efe891ab-d211-4d46-900a-109550bd9925
• NDC: 0904-6580
• Product Type: Human Prescription Drug
• Proprietary Name: Esomeprazole Magnesium
• Generic Name: Esomeprazole Magnesium
• Dosage Form: Capsule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2015-12-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078279
• Labeler Name: Major Pharmaceuticals
• Substance Name: ESOMEPRAZOLE MAGNESIUM
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0904-6580-61

100 BLISTER PACK in 1 CARTON (0904-6580-61) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

• Marketing Start Date: 2015-12-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0904-6580-61 [00904658061]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA078279
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-12-10
• Marketing End Date: 2015-12-10

Drug Details

Active Ingredients

Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM	20 mg/1

OpenFDA Data

• SPL SET ID: ba65c73d-fc7d-491e-aaaa-cf45a7783395
• Manufacturer:
  • Major Pharmaceuticals
• UNII:
  • R6DXU4WAY9
• RxNorm Concept Unique ID - RxCUI:
  • 606730
  • 606726

Pharmacological Class

• Proton Pump Inhibitor [EPC]
• Proton Pump Inhibitors [MoA]
• Cytochrome P450 2C19 Inhibitors [MoA]

NDC Crossover Matching brand name "Esomeprazole Magnesium" or generic name "Esomeprazole Magnesium"

NDC	Brand Name	Generic Name
0093-6450	Esomeprazole Magnesium	Esomeprazole Magnesium
0093-6451	Esomeprazole Magnesium	Esomeprazole Magnesium
0186-0382	Esomeprazole magnesium	Esomeprazole magnesium
0186-0384	Esomeprazole magnesium	Esomeprazole magnesium
67877-479	Esomeprazole magnesium	Esomeprazole magnesium
67877-478	Esomeprazole magnesium	Esomeprazole magnesium
68016-007	Esomeprazole Magnesium	Esomeprazole Magnesium
68071-3179	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM
68071-4213	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM
68071-4212	Esomeprazole Magnesium	Esomeprazole Magnesium
68071-4457	Esomeprazole Magnesium	Esomeprazole Magnesium
68071-4536	Esomeprazole Magnesium	Esomeprazole Magnesium
68071-4825	Esomeprazole Magnesium	Esomeprazole Magnesium
68196-977	Esomeprazole Magnesium	Esomeprazole Magnesium
68788-7201	Esomeprazole Magnesium	Esomeprazole Magnesium
68788-6922	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM
69842-898	esomeprazole magnesium	esomeprazole magnesium
69842-277	Esomeprazole Magnesium	Esomeprazole Magnesium
70518-0044	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM
70677-0069	Esomeprazole Magnesium	Esomeprazole Magnesium
71335-0987	Esomeprazole magnesium	Esomeprazole magnesium
71335-0709	Esomeprazole Magnesium	Esomeprazole Magnesium
71335-0807	Esomeprazole Magnesium	Esomeprazole Magnesium
71335-0052	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM
72036-800	Esomeprazole Magnesium	Esomeprazole Magnesium
0904-6581	Esomeprazole Magnesium	Esomeprazole Magnesium
0904-6580	Esomeprazole Magnesium	Esomeprazole Magnesium
11822-0898	esomeprazole magnesium	esomeprazole magnesium
13668-154	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM
13668-155	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM
16714-735	Esomeprazole Magnesium	Esomeprazole Magnesium
16714-736	Esomeprazole Magnesium	Esomeprazole Magnesium
30142-413	esomeprazole magnesium	esomeprazole magnesium
31722-573	Esomeprazole Magnesium	Esomeprazole Magnesium
31722-572	Esomeprazole Magnesium	Esomeprazole Magnesium
30142-261	Esomeprazole Magnesium	Esomeprazole Magnesium
37012-898	esomeprazole magnesium	esomeprazole magnesium
37808-898	esomeprazole magnesium	esomeprazole magnesium
37808-115	Esomeprazole Magnesium	Esomeprazole Magnesium
41250-900	esomeprazole magnesium	esomeprazole magnesium
42292-010	Esomeprazole Magnesium	Esomeprazole Magnesium
42292-009	Esomeprazole Magnesium	Esomeprazole Magnesium
42708-024	Esomeprazole Magnesium	Esomeprazole Magnesium
43598-407	Esomeprazole Magnesium	Esomeprazole Magnesium
43598-812	Esomeprazole Magnesium	Esomeprazole Magnesium
43598-509	Esomeprazole Magnesium	Esomeprazole Magnesium
43598-510	Esomeprazole Magnesium	Esomeprazole Magnesium
46122-538	Esomeprazole Magnesium	Esomeprazole Magnesium
45865-892	Esomeprazole Magnesium	Esomeprazole Magnesium
48792-7843	esomeprazole magnesium	esomeprazole magnesium