NDC 0186-5020Prescription (Rx only)FDA NDA · NDA021153

Nexium

Active substance: Esomeprazole magnesium

FDA labeler: AstraZeneca Pharmaceuticals LP

11 formulations • 21 package configurations
All 32 registered NDCs — click to copy
In one line

Nexium (Esomeprazole magnesium) NDC 0186-5020 converts to 00186-5020-31 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

FDA Approval & Market Entry Timeline

Official openFDA & DailyMed regulatory registration sequence
Listing: 0186-5020 Verified
1. Initial Approval
2001
First U.S. FDA clearance for Esomeprazole magnesium
2. FDA Application
NDA021153
Regulatory pathway: NDA
3. Market Entry Date
Mar 19, 2001
First commercial NDC distribution & launch date
4. Regulatory Status
Active Commercial Listing
Registration valid through Dec 31, 2027
Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel
NDC direct
Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).
Standard pharmacy claim — no J-Code required
11-digit HIPAA NDC
00186-5020-31
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
Self-Administered (Oral)
Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.
UB-04 revenue code
Rev 0250
0250 (General Pharmacy)
Qualifier: UN
Always verify NDC package code, billable multiplier, and invoice qualifier with specific payer guidelines before claim filing.
Complete drug registry

All registered strengths & packaging

Every registered strength and package for NEXIUM, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
20 mg/10186-5020-310186-502000186-5020-3130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-31)
20 mg/10186-5020-540186-502000186-5020-5490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5020-54)
40 mg/10186-5040-310186-504000186-5040-3130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-31)
40 mg/10186-5040-540186-504000186-5040-5490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0186-5040-54)
20 mg/150090-1492-050090-149250090-1492-003 BOTTLE in 1 CARTON (50090-1492-0) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
10 mg/10186-4010-010186-401000186-4010-0130 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4010-01)
20 mg/10186-4020-010186-402000186-4020-0130 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4020-01)
20 mg/10573-2450-020573-245000573-2450-021 BLISTER PACK in 1 CARTON (0573-2450-02) / 2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
20 mg/10573-2450-140573-245000573-2450-141 BOTTLE in 1 CARTON (0573-2450-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/10573-2450-280573-245000573-2450-282 BOTTLE in 1 CARTON (0573-2450-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/10573-2450-420573-245000573-2450-423 BOTTLE in 1 CARTON (0573-2450-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/10573-2450-430573-245000573-2450-433 BOTTLE in 1 BLISTER PACK (0573-2450-43) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/10573-2450-440573-245000573-2450-443 BOTTLE in 1 CARTON (0573-2450-44) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
2.5 mg/10186-4025-010186-402500186-4025-0130 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4025-01)
20 mg/10573-2451-140573-245100573-2451-141 BOTTLE in 1 CARTON (0573-2451-14) / 14 TABLET in 1 BOTTLE
20 mg/10573-2451-420573-245100573-2451-423 BOTTLE in 1 BLISTER PACK (0573-2451-42) / 14 TABLET in 1 BOTTLE
40 mg/10186-4040-010186-404000186-4040-0130 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4040-01)
20 mg/10573-2452-020573-245200573-2452-021 BLISTER PACK in 1 CARTON (0573-2452-02) / 2 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
20 mg/10573-2452-140573-245200573-2452-141 BOTTLE in 1 CARTON (0573-2452-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
20 mg/10573-2452-420573-245200573-2452-423 BOTTLE in 1 CARTON (0573-2452-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
5 mg/10186-4050-010186-405000186-4050-0130 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4050-01)
FDA drug label

Prescribing information

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary.

3 Label Sections
Uses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
Directions adults 18 years of age and older this product is to be used once a day (every 24 hours), every day for 14 days may take 1 to 4 days for full effect 14-Day Course of Treatment Repeated 14-Day Courses (if needed) swallow 1 capsule with a glass of water before eating in the morning take every day for 14 days do not take more than 1 capsule a day swallow whole. Do not crush or chew capsules. do not use for more than 14 days unless directed by your doctor you may repeat a 14-day course every 4 months do not take for more than 14 days or more often than every 4 months unless directed by a doctor children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.
Warnings Allergy alert: Do not use if you are allergic to esomeprazole Esomeprazole may cause severe skin reactions. Symptoms include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical attention right away. Do not use if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools heartburn with lightheadedness, sweating or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain These may be signs of a serious condition. See your doctor. Ask a doctor before use if you have had heartburn over 3 months. This may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if your heartburn continues or worsens you need to take this product for more than 14 days you need to take more than 1 course of treatment every 4 months you get diarrhea you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Search more NDCs & medical codes