NDC 69238-1050

Esomeprazole Magnesium

Esomeprazole Magnesium

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

• Product ID: 69238-1050_0208a196-14c6-4577-90f3-fb48f38a3cd5
• NDC: 69238-1050
• Product Type: Human Otc Drug
• Proprietary Name: Esomeprazole Magnesium
• Generic Name: Esomeprazole Magnesium
• Dosage Form: Capsule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2019-06-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA209716
• Labeler Name: Amneal Pharmaceuticals NY LLC
• Substance Name: ESOMEPRAZOLE MAGNESIUM
• Active Ingredient Strength: 20 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69238-1050-1

1 BOTTLE in 1 BLISTER PACK (69238-1050-1) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69238-1050-4)

• Marketing Start Date: 2019-06-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69238-1050-3 [69238105003]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209716
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-06-05

NDC 69238-1050-1 [69238105001]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209716
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-06-05

NDC 69238-1050-9 [69238105009]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209716
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-06-05

NDC 69238-1050-4 [69238105004]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209716
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-06-05

NDC 69238-1050-5 [69238105005]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209716
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-06-05

NDC 69238-1050-8 [69238105008]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209716
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-06-05

NDC 69238-1050-2 [69238105002]

Esomeprazole Magnesium CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA209716
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-06-05

Drug Details

Active Ingredients

Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM	20 mg/1

OpenFDA Data

• SPL SET ID: d13c22be-f5bd-4ea8-8081-bdfac9e7fb1b
• Manufacturer:
  • Amneal Pharmaceuticals NY LLC
• UNII:
  • R6DXU4WAY9

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