Prescription drug · ANDA

Esomeprazole Magnesium NDC 72189-318

Esomeprazole magnesium 40 mg/1 · Capsule, Delayed release · Oral · Direct Rx

NDC codes

FDA NDC Directory
Product NDC (as listed)72189-318Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0318Add 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
72189-318-30721890318307218903183030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72189-318-30)Marketed from Jan 19, 2022

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 — 40 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Direct RxNDC labeler code 72189
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211977
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 72189-318_2c3d1a7e-adf4-c587-e063-6394a90a0637SPL ID 2c3d1a7e-adf4-c587-e063-6394a90a0637SPL set ID d5f56bd4-3a59-6857-e053-2995a90a6e00RxCUI 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

N472189031830 followed by a unit qualifier and the quantity

Package 72189-0318-30. 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)

1.1 Treatment of Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole magnesium delayed-release capsules may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gast…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-318

What is NDC 72189-318?
72189-318 is the product NDC for Esomeprazole Magnesium, Esomeprazole magnesium 40 mg/1 capsule, delayed release, listed with the FDA by Direct Rx. It has 1 package NDC, 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?
Direct Rx, NDC labeler code 72189. 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 211977

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

FDA NDC Directory listings under ANDA 211977
ProductStrengthForm · routeLabelerProduct NDC
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6198
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-4581
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-877
Esomeprazole Magnesium DResomeprazole magnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0331
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7896
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7360
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-2018
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-905
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-2040
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0419
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-904
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0420
Esomeprazole DREsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralDirect_Rx72189-381
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralCamber Pharmaceuticals, Inc.31722-664
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralCamber Pharmaceuticals, Inc.31722-665
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAmerican Health Packaging60687-934

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in