NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1170Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1170Add 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
71335-1170-17133511700130 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-1)Marketed from Mar 25, 2019
71335-1170-27133511700210 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-2)Marketed from Jul 1, 2019
71335-1170-37133511700360 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-3)Marketed from May 7, 2019
71335-1170-47133511700490 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-4)Marketed from Jun 10, 2019
71335-1170-57133511700542 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-5)Marketed from May 17, 2024
71335-1170-671335117006120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-6)Marketed from May 17, 2024
71335-1170-771335117007180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-7)Marketed from May 17, 2024
71335-1170-87133511700820 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-8)Marketed from Sep 4, 2019

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 magnesium20 mg/1
Dosage form
Capsule, Delayed release pellets
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205563
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 71335-1170_44f6187b-ca56-43bb-a345-3dc36f159a5bSPL ID 44f6187b-ca56-43bb-a345-3dc36f159a5bSPL set ID fed0e554-7d61-4957-9b91-356f3abc0777RxCUI 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

N471335117001 followed by a unit qualifier and the quantity

Package 71335-1170-01. 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 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 ) Helic

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205563

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

FDA NDC Directory listings under ANDA 205563
ProductStrengthForm · routeLabelerProduct NDC
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed release pelletsOralLannett Company, Inc.62175-820
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed release pelletsOralLannett Company, Inc.62175-840

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