NDC codes

FDA NDC Directory
Product NDC (as listed)70849-200Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70849-0200Add 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
70849-200-30708490200307084902003030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70849-200-30)Marketed from Sep 15, 2016

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 Strontium
Generic name (nonproprietary)
esomeprazole strontium
Active ingredients
Esomeprazole strontium — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
R2 Pharma, LLCNDC labeler code 70849
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 202342
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers
Product ID 70849-200_3d19523d-7cb5-2f2f-e054-00144ff88e88SPL ID 3d19523d-7cb5-2f2f-e054-00144ff88e88SPL set ID 3c916d32-f9e9-1d15-e054-00144ff88e88RxCUI 1810787, 1810789UNII C5N25H3803UPC 0370849400300, 0370849200306
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

N470849020030 followed by a unit qualifier and the quantity

Package 70849-0200-30. 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)

1.INDICATIONS & USAGE SECTION 1.1 Treatment of Gastroesophageal Reflux Disease (GERD) in Adults Healing of Erosive Esophagitis Esomeprazole strontium is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole strontium may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole strontium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomepraz…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70849-200

What is NDC 70849-200?
70849-200 is the product NDC for Esomeprazole Strontium, Esomeprazole strontium 20 mg/1 capsule, delayed release, listed with the FDA by R2 Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Esomeprazole Strontium.
What is the active ingredient?
Esomeprazole strontium.
Who is the labeler?
R2 Pharma, LLC, NDC labeler code 70849. 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 Strontium?
1 other product NDC are listed under this name. See all Esomeprazole Strontium 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 Strontium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Esomeprazole StrontiumEsomeprazole strontium 40 mg/1Capsule, Delayed releaseOralR2 Pharma, LLC70849-40070849-0400-30

Other NDCs under NDA 202342

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

FDA NDC Directory listings under NDA 202342
ProductStrengthForm · routeLabelerProduct NDC
Esomeprazole StrontiumEsomeprazole strontium 40 mg/1Capsule, Delayed releaseOralR2 Pharma, LLC70849-400

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