Prescription drug · ANDA

Esomeprazole Magnesium NDC 45865-163

Esomeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · Medsource Pharmaceuticals

NDC codes

FDA NDC Directory
Product NDC (as listed)45865-163Labeler and product segments. Claims need a package NDC.
Product NDC at billing width45865-0163Add 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
45865-163-30458650163304586501633030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-30)Marketed from Jul 28, 2022
45865-163-60458650163604586501636060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-163-60)Marketed from Dec 28, 2020

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 — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Medsource PharmaceuticalsNDC labeler code 45865
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078279
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 45865-163_1278c4e8-89c4-94b5-e063-6294a90a7d73SPL ID 1278c4e8-89c4-94b5-e063-6294a90a7d73SPL set ID 1278cf6f-cc7a-462b-e063-6394a90a34e5RxCUI 606726UNII 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

N445865016330 followed by a unit qualifier and the quantity

Package 45865-0163-30. 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 is 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 ) Helicobacter pylori eradicatio…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 45865-163

What is NDC 45865-163?
45865-163 is the product NDC for Esomeprazole Magnesium, Esomeprazole magnesium 20 mg/1 capsule, delayed release, listed with the FDA by Medsource Pharmaceuticals. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Esomeprazole Magnesium.
What is the active ingredient?
Esomeprazole magnesium.
Who is the labeler?
Medsource Pharmaceuticals, NDC labeler code 45865. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Esomeprazole Magnesium?
179 other product NDCs are listed under this name. See all Esomeprazole Magnesium NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Esomeprazole Magnesium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-477670518-4776-00
Esomeprazole MagnesiumEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralChain Drug Marketing Association, Inc.83324-32883324-0328-1483324-0328-42
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-87760760-0877-60
Esomeprazole MagnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-56372288-0563-01
esomeprazole magnesiumesomeprazole magnesium dihydrateEsomeprazole magnesium dihydrate 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-78072288-0780-03
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAmerican Health Packaging60687-93460687-0934-21
esomeprazole magnesiumesomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralAmazon.com Services LLC72288-66972288-0669-0172288-0669-03
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralH-E-B37808-64637808-0646-4137808-0646-4537808-0646-82
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralRising Pharma Holdings, Inc.64980-66464980-0664-1964980-0664-41
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1CapsuleOralYYBA CORP73581-01473581-0014-42

All 180 Esomeprazole Magnesium NDCs

Other NDCs under ANDA 078279

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

FDA NDC Directory listings under ANDA 078279
ProductStrengthForm · routeLabelerProduct NDC
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals,Inc.68071-3735
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-5134
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6943
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralProficient Rx LP71205-143
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralPD-Rx Pharmaceuticals, Inc.72789-391
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralAvPAK50268-272
Esomeprazole MagnesiumEsomeprazole magnesium trihydrate 40 mg/1Capsule, Delayed releaseOralMajor Pharmaceuticals0904-6581
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-964
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralNorthStar Rx LLC16714-979
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralNorthStar Rx LLC16714-980
Esomeprazole MagnesiumEsomeprazole magnesium trihydrate 20 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-8511
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralDr. Reddy's Laboratories Inc43598-510
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralDr. Reddy's Laboratories Inc43598-509
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals, Inc.68071-3934

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