Over-the-counter drug · ANDA

Esomeprazole (Esomeprazole magnesium) NDC 51316-715

Esomeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · CVS

NDC codes

FDA NDC Directory
Product NDC (as listed)51316-715Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51316-0715Add 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
51316-715-1451316071514513160715141 BOTTLE in 1 CARTON (51316-715-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 2, 2022
51316-715-2851316071528513160715282 BOTTLE in 1 CARTON (51316-715-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 2, 2022
51316-715-4251316071542513160715423 BOTTLE in 1 CARTON (51316-715-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Sep 2, 2022

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
Generic name (nonproprietary)
esomeprazole magnesium
Active ingredients
Esomeprazole magnesium — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
CVSNDC labeler code 51316
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212866
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 51316-715_5bc222ed-dfb7-30d7-e063-6394a90ad1ddSPL ID 5bc222ed-dfb7-30d7-e063-6394a90ad1dd
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

N451316071514 followed by a unit qualifier and the quantity

Package 51316-0715-14. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 51316-715

What is NDC 51316-715?
51316-715 is the product NDC for Esomeprazole (esomeprazole magnesium), Esomeprazole magnesium 20 mg/1 capsule, delayed release, listed with the FDA by CVS. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Esomeprazole (Esomeprazole magnesium).
What is the active ingredient?
Esomeprazole magnesium.
Who is the labeler?
CVS, NDC labeler code 51316. 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?
10 other product NDCs are listed under this name. See all Esomeprazole 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralGERI-CARE PHARMACEUTICALS, CORP57896-74057896-0740-42
esomeprazoleEsomeprazole 20 mg/1Capsule, Delayed releaseOralMacleods Pharmaceuticals Limited33342-30633342-0306-0733342-0306-10
esomeprazoleEsomeprazole 40 mg/1Capsule, Delayed releaseOralMacleods Pharmaceuticals Limited33342-30733342-0307-0733342-0307-10
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralYYBA CORP73581-01373581-0013-42
EsomeprazoleEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSafeway, Inc.21130-92621130-0926-1421130-0926-2821130-0926-42
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1TabletOralHARRIS TEETER72036-98272036-0982-42
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralOhm Laboratories Inc.51660-02751660-0027-1451660-0027-2751660-0027-44
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium trihydrate 20 mg/1Capsule, Delayed releaseOralINNOVUS PHARMACEUTICALS, INC.57483-90057483-0900-42
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralVALU MERCHANDISERS COMPANY63941-99963941-0999-1463941-0999-42
esomeprazoleEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralTHE KROGER COMPANY30142-98930142-0989-28

Other NDCs under ANDA 212866

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

FDA NDC Directory listings under ANDA 212866
ProductStrengthForm · routeLabelerProduct NDC
EsomeprazoleEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralSafeway, Inc.21130-926
esomeprazoleEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralTHE KROGER COMPANY30142-989
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralOhm Laboratories Inc.51660-027
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium trihydrate 20 mg/1Capsule, Delayed releaseOralINNOVUS PHARMACEUTICALS, INC.57483-900
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralGERI-CARE PHARMACEUTICALS, CORP57896-740
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralVALU MERCHANDISERS COMPANY63941-999
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1TabletOralHARRIS TEETER72036-982
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralYYBA CORP73581-013
Esomeprazole MagnesiumEsomeprazole magnesium 20 mg/1Capsule, Delayed releaseOralLITTLE PHARMA, INC.72559-011

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