NDC codes

FDA NDC Directory
Product NDC (as listed)67877-479Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0479Add 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
67877-479-0567877047905500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-479-05)Marketed from Oct 20, 2017
67877-479-10678770479101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-479-10)Marketed from Oct 20, 2017
67877-479-306787704793030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-479-30)Marketed from Oct 20, 2017
67877-479-386787704793810 BLISTER PACK in 1 CARTON (67877-479-38) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Oct 20, 2017
67877-479-906787704799090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-479-90)Marketed from Oct 20, 2017

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
Ascend Laboratories, LLCNDC labeler code 67877
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208333
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 67877-479_c6b5c112-5f5b-453a-836f-54bac8c7dca9SPL ID c6b5c112-5f5b-453a-836f-54bac8c7dca9SPL set ID f3d4a0d7-77fd-496e-8dfa-2b2dbace4bacRxCUI 606726, 606730UNII R6DXU4WAY9UPC 0367877478104
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

N467877047905 followed by a unit qualifier and the quantity

Package 67877-0479-05. 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 67877-479

What is NDC 67877-479?
67877-479 is the product NDC for Esomeprazole magnesium, Esomeprazole magnesium 40 mg/1 capsule, delayed release, listed with the FDA by Ascend Laboratories, LLC. It has 5 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?
Ascend Laboratories, LLC, NDC labeler code 67877. 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?
174 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 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
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralAvPAK50268-27250268-0272-13
Esomeprazole MagnesiumEsomeprazole magnesium 40 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-458170518-4581-00

All 175 Esomeprazole magnesium NDCs

Other NDCs under ANDA 208333

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

FDA NDC Directory listings under ANDA 208333
ProductStrengthForm · routeLabelerProduct NDC
Esomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralAscend Laboratories, LLC67877-478

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