What is NDC 43547-002?

43547-002 is the product NDC for Esomeprazole magnesium, Esomeprazole magnesium trihydrate 40 mg/1 capsule, delayed release, listed with the FDA by Solco Healthcare US LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Esomeprazole magnesium trihydrate.

Solco Healthcare US LLC, NDC labeler code 43547. 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 43547-002

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-002Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0002Add 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
43547-002-03	4354700020343547000203	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-03)Marketed from Mar 28, 2023
43547-002-09	4354700020943547000209	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-09)Marketed from Mar 28, 2023
43547-002-11	4354700021143547000211	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-002-11)Marketed from Mar 28, 2023

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 magnesium
Generic name (nonproprietary): esomeprazole magnesium
Active ingredients: Esomeprazole magnesium trihydrate — 40 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Solco Healthcare US LLCNDC labeler code 43547
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214920
Marketing start: Mar 28, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 43547-002_3d2a1a0f-c770-4f46-851e-0697e4f5de4cSPL ID 3d2a1a0f-c770-4f46-851e-0697e4f5de4cSPL set ID 3cd80c04-43a2-4be3-b831-ebccc273a0d2RxCUI 606726, 606730UNII R6DXU4WAY9UPC 0343547001032, 0343547002039
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

N443547000203 followed by a unit qualifier and the quantity

Package 43547-0002-03. 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 Dec 28, 2023.

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.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43547-002

What is NDC 43547-002?: 43547-002 is the product NDC for Esomeprazole magnesium, Esomeprazole magnesium trihydrate 40 mg/1 capsule, delayed release, listed with the FDA by Solco Healthcare US LLC. It has 3 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 trihydrate.
Who is the labeler?: Solco Healthcare US LLC, NDC labeler code 43547. 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 214920

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

FDA NDC Directory listings under ANDA 214920
Product	Strength	Form · route	Labeler	Product NDC
Esomeprazole magnesium	Esomeprazole magnesium trihydrate 20 mg/1	Capsule, Delayed releaseOral	Solco Healthcare US LLC	43547-001