What is NDC 33342-307?

33342-307 is the product NDC for esomeprazole, Esomeprazole 40 mg/1 capsule, delayed release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

esomeprazole NDC 33342-307 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-307Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0307Add 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	Copy
33342-307-07	33342030707	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-307-07)Marketed from Oct 23, 2024
33342-307-10	33342030710	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-307-10)Marketed from Oct 23, 2024

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
Active ingredients: Esomeprazole — 40 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208511
Marketing start: Oct 23, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 33342-307_d68c9247-91c7-4e0f-adc4-2cfa7446580fSPL ID d68c9247-91c7-4e0f-adc4-2cfa7446580fSPL set ID d68c9247-91c7-4e0f-adc4-2cfa7446580fRxCUI 606726, 606730UNII N3PA6559FTUPC 0333342307101, 0333342307071
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

N433342030707 followed by a unit qualifier and the quantity

Package 33342-0307-07. 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 Nov 30, 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-307

What is NDC 33342-307?: 33342-307 is the product NDC for esomeprazole, Esomeprazole 40 mg/1 capsule, delayed release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: esomeprazole.
What is the active ingredient?: Esomeprazole.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Esomeprazoleesomeprazole magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	GERI-CARE PHARMACEUTICALS, CORP	57896-740	57896-0740-42
esomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-306	33342-0306-0733342-0306-10
Esomeprazoleesomeprazole magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	YYBA CORP	73581-013	73581-0013-42
Esomeprazole	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Safeway, Inc.	21130-926	21130-0926-1421130-0926-2821130-0926-42
Esomeprazoleesomeprazole magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	CVS	51316-715	51316-0715-1451316-0715-2851316-0715-42
Esomeprazoleesomeprazole magnesium	Esomeprazole magnesium 20 mg/1	TabletOral	HARRIS TEETER	72036-982	72036-0982-42
Esomeprazoleesomeprazole magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	Ohm Laboratories Inc.	51660-027	51660-0027-1451660-0027-2751660-0027-44
Esomeprazoleesomeprazole magnesium	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	VALU MERCHANDISERS COMPANY	63941-999	63941-0999-1463941-0999-42
Esomeprazoleesomeprazole magnesium	Esomeprazole magnesium trihydrate 20 mg/1	Capsule, Delayed releaseOral	INNOVUS PHARMACEUTICALS, INC.	57483-900	57483-0900-42
esomeprazole	Esomeprazole magnesium 20 mg/1	Capsule, Delayed releaseOral	THE KROGER COMPANY	30142-989	30142-0989-28

Other NDCs under ANDA 208511

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

FDA NDC Directory listings under ANDA 208511
Product	Strength	Form · route	Labeler	Product NDC
esomeprazole	Esomeprazole 20 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-306