What is NDC 71335-0807?

71335-0807 is the product NDC for Esomeprazole Magnesium, Esomeprazole magnesium dihydrate 20 mg/1 capsule, delayed release, listed with the FDA by Bryant Ranch Prepack. It has 8 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Esomeprazole magnesium dihydrate.

Bryant Ranch Prepack, NDC labeler code 71335. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Esomeprazole Magnesium NDC 71335-0807

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0807Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0807Add 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 NDC	11-digit (billing)	Package
71335-0807-1	7133508070171335080701	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-1)Marketed from Jun 19, 2018
71335-0807-2	7133508070271335080702	10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-2)Marketed from May 29, 2018
71335-0807-3	7133508070371335080703	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-3)Marketed from Jul 11, 2018
71335-0807-4	7133508070471335080704	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-4)Marketed from Jul 16, 2018
71335-0807-5	7133508070571335080705	42 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-5)Marketed from Jul 9, 2024
71335-0807-6	7133508070671335080706	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-6)Marketed from Jul 9, 2024
71335-0807-7	7133508070771335080707	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-7)Marketed from Jul 9, 2024
71335-0807-8	7133508070871335080708	20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0807-8)Marketed from Jul 9, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 dihydrate — 20 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205606
Marketing start: Apr 21, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 71335-0807_e6e99a77-7dd9-4fd5-a91a-cb09a573bd58SPL ID e6e99a77-7dd9-4fd5-a91a-cb09a573bd58SPL set ID 009794ae-8199-4176-9dc6-4c5e752d845cRxCUI 606726UNII 36H71644EQ
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

N471335080701 followed by a unit qualifier and the quantity

Package 71335-0807-01. 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 Jul 9, 2024.

Indications (excerpt from the label)

Esomeprazole magnesium delayed-release capsules are 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 ) Heli…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0807

What is NDC 71335-0807?: 71335-0807 is the product NDC for Esomeprazole Magnesium, Esomeprazole magnesium dihydrate 20 mg/1 capsule, delayed release, listed with the FDA by Bryant Ranch Prepack. It has 8 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 dihydrate.
Who is the labeler?: Bryant Ranch Prepack, NDC labeler code 71335. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	REMEDYREPACK INC.	70518-4776	70518-4776-00
Esomeprazole Magnesium	Esomeprazole magnesium dihydrate 20 mg/1	Capsule, Delayed releaseOral	Chain Drug Marketing Association, Inc.	83324-328	83324-0328-1483324-0328-42
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	St. Mary's Medical Park Pharmacy	60760-877	60760-0877-60
Esomeprazole Magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-563	72288-0563-01
esomeprazole magnesiumesomeprazole magnesium dihydrate	Esomeprazole magnesium dihydrate 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-780	72288-0780-03
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	American Health Packaging	60687-934	60687-0934-21
esomeprazole magnesiumesomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Amazon.com Services LLC	72288-669	72288-0669-0172288-0669-03
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	H-E-B	37808-646	37808-0646-4137808-0646-4537808-0646-82
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Rising Pharma Holdings, Inc.	64980-664	64980-0664-1964980-0664-41
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	CapsuleOral	YYBA CORP	73581-014	73581-0014-42

All 180 Esomeprazole Magnesium NDCs

Other NDCs under ANDA 205606

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

FDA NDC Directory listings under ANDA 205606
Product	Strength	Form · route	Labeler	Product NDC
Esomeprazole Magnesium	Esomeprazole magnesium trihydrate 40 mg/1	Capsule, Delayed releaseOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8628
Esomeprazole Magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-7990
Esomeprazole Magnesium	Esomeprazole magnesium 40 mg/1	Capsule, Delayed releaseOral	A-S Medication Solutions	50090-7991
Esomeprazole Magnesium	Esomeprazole magnesium dihydrate 40 mg/1	Capsule, Delayed releaseOral	Aurobindo Pharma Limited	65862-784
Esomeprazole Magnesium	Esomeprazole magnesium dihydrate 20 mg/1	Capsule, Delayed releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-352
Esomeprazole Magnesium DResomeprazole magnesium	Esomeprazole magnesium dihydrate 20 mg/1	Capsule, Delayed releaseOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0111