What is NDC 53041-664?

53041-664 is the product NDC for Omeprazole, Sodium bicarbonate, Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 capsule, listed with the FDA by Guardian Drug Company. It has 1 package NDC, shown above in 10- and 11-digit form.

Guardian Drug Company, NDC labeler code 53041. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Omeprazole, Sodium bicarbonate?

5 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Omeprazole, Sodium bicarbonate NDC 53041-664

NDC codes

FDA NDC Directory

Product NDC (as listed)53041-664Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53041-0664Add 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
53041-664-77	5304106647753041066477	30 CAPSULE in 1 BOTTLE (53041-664-77)Marketed from May 7, 2020

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): Omeprazole, Sodium bicarbonate
Generic name (nonproprietary): omeprazole, sodium bicarbonate
Active ingredients: Omeprazole — 20 mg/1Sodium bicarbonate — 1100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Guardian Drug CompanyNDC labeler code 53041
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212587
Marketing start: May 7, 2020
Listing expires: Dec 31, 2026
Other FDA classes: Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 53041-664_27536955-37df-4dcc-ad75-2b364fe95460SPL ID 27536955-37df-4dcc-ad75-2b364fe95460SPL set ID e5c6c2cf-fb3b-456a-a0a0-be396d6f8319RxCUI 616539, 616541UNII KG60484QX9, 8MDF5V39QO
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

N453041066477 followed by a unit qualifier and the quantity

Package 53041-0664-77. 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 8, 2022.

Indications (excerpt from the label)

Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the: short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. The efficacy of Omeprazole and Sodium Bicarbonate capsules used for longer than 8 weeks in patient with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 53041-664

What is NDC 53041-664?: 53041-664 is the product NDC for Omeprazole, Sodium bicarbonate, Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 capsule, listed with the FDA by Guardian Drug Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Omeprazole, Sodium bicarbonate.
What is the active ingredient?: Omeprazole, Sodium bicarbonate.
Who is the labeler?: Guardian Drug Company, NDC labeler code 53041. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Omeprazole, Sodium bicarbonate?: 5 other product NDCs are listed under this name. See all Omeprazole, Sodium bicarbonate 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 Omeprazole, Sodium bicarbonate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Omeprazole/Sodium Bicarbonateomeprazole	Omeprazole 20 mg/1700mg; Sodium bicarbonate 1680 mg/1700mg	Powder, For suspensionOral	Strides Pharma Science Limited	64380-182	64380-0182-02
Omeprazole/Sodium Bicarbonateomeprazole	Omeprazole 40 mg/1720mg; Sodium bicarbonate 1680 mg/1720mg	Powder, For suspensionOral	Strides Pharma Science Limited	64380-183	64380-0183-02
Omeprazole, Sodium bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	Guardian Drug Company	53041-663	53041-0663-77
omeprazole sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	Cipla USA Inc.	69097-913	69097-0913-0269097-0913-12
omeprazole sodium bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	Cipla USA Inc.	69097-914	69097-0914-0269097-0914-12

Other NDCs under ANDA 212587

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

FDA NDC Directory listings under ANDA 212587
Product	Strength	Form · route	Labeler	Product NDC
Omeprazole, Sodium bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	Guardian Drug Company	53041-663