Over-the-counter drug · ANDA

Esomeprazole (Esomeprazole magnesium) NDC 51660-027

Esomeprazole magnesium 20 mg/1 · Capsule, Delayed release · Oral · Ohm Laboratories Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)51660-027Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51660-0027Add 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
51660-027-1451660002714516600027141 BOTTLE in 1 CARTON (51660-027-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Aug 14, 2020
51660-027-2751660002727516600027272 BOTTLE in 1 CARTON (51660-027-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Aug 14, 2020
51660-027-4451660002744516600027443 BOTTLE in 1 CARTON (51660-027-44) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLEMarketed from Aug 14, 2020

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
Ohm Laboratories Inc.NDC labeler code 51660
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 51660-027_53a1652c-a8b0-ed15-e063-6394a90a0a6bSPL ID 53a1652c-a8b0-ed15-e063-6394a90a0a6bSPL set ID e6d19b0a-44a8-42fe-8a6c-717ecb3ac1c4RxCUI 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

N451660002714 followed by a unit qualifier and the quantity

Package 51660-0027-14. 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 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 51660-027

What is NDC 51660-027?
51660-027 is the product NDC for Esomeprazole (esomeprazole magnesium), Esomeprazole magnesium 20 mg/1 capsule, delayed release, listed with the FDA by Ohm Laboratories Inc.. 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?
Ohm Laboratories Inc., NDC labeler code 51660. 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/1Capsule, Delayed releaseOralCVS51316-71551316-0715-1451316-0715-2851316-0715-42
Esomeprazoleesomeprazole magnesiumEsomeprazole magnesium 20 mg/1TabletOralHARRIS TEETER72036-98272036-0982-42
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 releaseOralCVS51316-715
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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