Prescription drug · ANDA

Esomeprazole Magnesium NDC 71335-2018

Esomeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2018Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2018Add 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
71335-2018-1713352018017133520180130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-1)Marketed from Feb 10, 2022
71335-2018-2713352018027133520180210 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-2)Marketed from Feb 10, 2022
71335-2018-3713352018037133520180360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-3)Marketed from Feb 10, 2022
71335-2018-4713352018047133520180490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-4)Marketed from Feb 10, 2022
71335-2018-5713352018057133520180542 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-5)Marketed from Feb 10, 2022
71335-2018-67133520180671335201806120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-6)Marketed from Feb 10, 2022
71335-2018-77133520180771335201807180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-7)Marketed from Feb 10, 2022
71335-2018-8713352018087133520180820 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2018-8)Marketed from Feb 10, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Bryant Ranch PrepackNDC labeler code 71335
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 71335-2018_d95a3df7-b940-4a73-8238-3608e58ca70bSPL ID d95a3df7-b940-4a73-8238-3608e58ca70bSPL set ID 7778bf7c-52f7-44b3-ac2c-e5a25f6967b7RxCUI 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

N471335201801 followed by a unit qualifier and the quantity

Package 71335-2018-01. 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 capsule, is a proton pump inhibitor indicated for the following: • Treatment of gastroesophageal reflux disease (GERD) (1.1) • Risk reduction of NSAID-associated gastric ulcer (1.2) • H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3) • Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2018

What is NDC 71335-2018?
71335-2018 is the product NDC for Esomeprazole Magnesium, Esomeprazole magnesium 20 mg/1 capsule, delayed release, listed with the FDA by Bryant Ranch Prepack. It has 8 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 40 mg/1Capsule, Delayed releaseOralDirect Rx72189-318
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