Prescription drug · ANDA

Esomeprazole Magnesium NDC 71205-143

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

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-143Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0143Add 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
71205-143-307120501433030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-143-30)Marketed from Dec 10, 2018
71205-143-607120501436060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-143-60)Marketed from Dec 10, 2018
71205-143-907120501439090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-143-90)Marketed from Dec 11, 2018

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
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 71205-143_a1a1941e-0c5f-486e-84d0-321d53061b34SPL ID a1a1941e-0c5f-486e-84d0-321d53061b34SPL set ID 9224142a-6e14-4ca3-9e72-506ff9fbd0e1RxCUI 606730UNII R6DXU4WAY9UPC 0371205143305
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

N471205014330 followed by a unit qualifier and the quantity

Package 71205-0143-30. 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 delayed-release capsule USP is a proton pump inhibitor indicated for the following: 5. Treatment of gastroesophageal reflux disease (GERD) ( 1.1 ) 6. Risk reduction of NSAID-associated gastric ulcer ( 1.2 ) 7. H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3) 8. 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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 releaseOralMedsource Pharmaceuticals45865-163
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 trihydrate 40 mg/1Capsule, Delayed releaseOralMajor Pharmaceuticals0904-6581
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
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralPD-Rx Pharmaceuticals, Inc.72789-391
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 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 releaseOralAvPAK50268-272
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-964

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