Prescription drug · ANDA

Esomeprazole Magnesium NDC 59651-561

Esomeprazole magnesium trihydrate 20 mg/1 · Capsule, Delayed release · Oral · Aurobindo Pharma Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)59651-561Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0561Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
59651-561-0159651056101100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-561-01)Marketed from Nov 20, 2023
59651-561-14596510561141 BLISTER PACK in 1 CARTON (59651-561-14) / 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Nov 20, 2023
59651-561-305965105613030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-561-30)Marketed from Nov 20, 2023
59651-561-905965105619090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-561-90)Marketed from Nov 20, 2023
59651-561-99596510561991000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-561-99)Marketed from Nov 20, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Esomeprazole Magnesium
Generic name (nonproprietary)
esomeprazole magnesium
Active ingredients
Esomeprazole magnesium trihydrate — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205606
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 59651-561_23ef720d-d1c4-498e-b54a-ecaf96e19fcbSPL ID 23ef720d-d1c4-498e-b54a-ecaf96e19fcbSPL set ID 7038a0bc-99b2-4a6e-9b9a-0646ec187706RxCUI 606726, 606730UNII R6DXU4WAY9
Pharmacologic class
Proton Pump Inhibitor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N459651056101 followed by a unit qualifier and the quantity

Package 59651-0561-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1 ) Maintenance of healing of EE in adults. ( 1.2 ) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3 ) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4 ) Heli…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205606

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205606
ProductStrengthForm · routeLabelerProduct NDC
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralPD-Rx Pharmaceuticals, Inc.72789-352
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralAurobindo Pharma Limited65862-783
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7990
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 40 mg/1Capsule, Delayed releaseOralAurobindo Pharma Limited65862-784
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7991
Esomeprazole MagnesiumEsomeprazole magnesium trihydrate 40 mg/1Capsule, Delayed releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8628
Esomeprazole MagnesiumEsomeprazole magnesium trihydrate 40 mg/1Capsule, Delayed releaseOralAurobindo Pharma Limited59651-562
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-0807
Esomeprazole Magnesium DResomeprazole magnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0111

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Esomeprazole Magnesium NDC 59651-561 | Med-Code