NDC codes

FDA NDC Directory
Product NDC (as listed)63868-425Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63868-0425Add 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
63868-425-1463868042514638680425141 BOTTLE in 1 CARTON (63868-425-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 6, 2018
63868-425-2863868042528638680425282 BOTTLE in 1 CARTON (63868-425-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Mar 15, 2019
63868-425-4263868042542638680425423 BOTTLE in 1 CARTON (63868-425-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Jul 6, 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 — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
CHAIN DRUG MARKETING ASSOCIATION INCNDC labeler code 63868
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207673
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 63868-425_241fe5f8-399c-5ac9-fc77-f078e69ecb65SPL ID 241fe5f8-399c-5ac9-fc77-f078e69ecb65SPL set ID f95053ab-d6c5-ee92-58d1-6f203873f79cRxCUI 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

N463868042514 followed by a unit qualifier and the quantity

Package 63868-0425-14. 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)

Use(s) treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63868-425

What is NDC 63868-425?
63868-425 is the product NDC for Esomeprazole Magnesium, Esomeprazole magnesium 20 mg/1 capsule, delayed release, listed with the FDA by CHAIN DRUG MARKETING ASSOCIATION INC. It has 3 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?
CHAIN DRUG MARKETING ASSOCIATION INC, NDC labeler code 63868. 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 207673

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

FDA NDC Directory listings under ANDA 207673
ProductStrengthForm · routeLabelerProduct NDC
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralWalgreens Company0363-3298
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralThe Kroger Co.30142-261
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralHEB37808-115
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralDr. Reddy's Laboratories Inc.43598-812
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralDiscount Drug Mart, Inc53943-527

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