What is NDC 0113-0058?

0113-0058 is the product NDC for Good Sense Omeprazole and Sodium Bicarbonate, Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 capsule, gelatin coated, listed with the FDA by L. Perrigo Company. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Good Sense Omeprazole and Sodium Bicarbonate (Omeprazole, sodium bicarbonate).

What is the active ingredient?

Omeprazole, Sodium bicarbonate.

L. Perrigo Company, NDC labeler code 0113. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Good Sense Omeprazole and Sodium Bicarbonate?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 0113-0058

NDC codes

FDA NDC Directory

Product NDC (as listed)0113-0058Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00113-0058Add 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
0113-0058-03	0011300580300113005803	3 BOTTLE in 1 CARTON (0113-0058-03) / 14 CAPSULE, GELATIN COATED in 1 BOTTLEMarketed from Jun 19, 2017

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Good Sense Omeprazole and Sodium Bicarbonate
Generic name (nonproprietary): omeprazole, sodium bicarbonate
Active ingredients: Omeprazole — 20 mg/1Sodium bicarbonate — 1100 mg/1
Dosage form: Capsule, Gelatin coated
Route: Oral
Labeler: L. Perrigo CompanyNDC labeler code 0113
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201361
Marketing start: Jun 19, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2C19 Inhibitors (Mechanism)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 0113-0058_6916a481-6168-4c6f-8889-d8a207ce9d97SPL ID 6916a481-6168-4c6f-8889-d8a207ce9d97SPL set ID bcf32242-de17-4da1-b707-4ce26262eb78RxCUI 616539UNII KG60484QX9, 8MDF5V39QO
Pharmacologic class: Osmotic Laxative; 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

N400113005803 followed by a unit qualifier and the quantity

Package 00113-0058-03. 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 Nov 16, 2020.

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 0113-0058

What is NDC 0113-0058?: 0113-0058 is the product NDC for Good Sense Omeprazole and Sodium Bicarbonate, Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 capsule, gelatin coated, listed with the FDA by L. Perrigo Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Good Sense Omeprazole and Sodium Bicarbonate (Omeprazole, sodium bicarbonate).
What is the active ingredient?: Omeprazole, Sodium bicarbonate.
Who is the labeler?: L. Perrigo Company, NDC labeler code 0113. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Good Sense Omeprazole and Sodium Bicarbonate?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 201361

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

FDA NDC Directory listings under ANDA 201361
Product	Strength	Form · route	Labeler	Product NDC
basic care omeprazole and sodium bicarbonateomeprazole, sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	Amazon.com Services LLC	72288-732
omeprazole and sodium bicarbonateomeprazole, sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	Meijer Distribution Inc	41250-938
Omeprazole and sodium bicarbonateomeprazole, sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	H E B	37808-732
Zegerid OTComepraole, sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	Riley Consumer Care LLC	82632-699
omeprazole and sodium bicarbonateomeprazole, sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	Amazon.com Services LLC	72288-564
Omeprazole and sodium bicarbonateomeprazole, sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	Walgreen Company	0363-0732
equate omeprazole and sodium bicarbonateomeprazole, sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	WALMART INC.	79903-013
Omeprazole and Sodium Bicarbonateomeprazole, sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	CVS Pharmacy	59779-732

Good Sense Omeprazole and Sodium Bicarbonate (Omeprazole, sodium bicarbonate) NDC 0113-0058