What is NDC 50228-363?

50228-363 is the product NDC for Omeprazole and Sodium Bicarbonate, Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 capsule, listed with the FDA by ScieGen Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Omeprazole, Sodium bicarbonate.

ScieGen Pharmaceuticals, Inc., NDC labeler code 50228. 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 and Sodium Bicarbonate?

19 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Omeprazole and Sodium Bicarbonate NDC 50228-363

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-363Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0363Add 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
50228-363-05	5022803630550228036305	500 CAPSULE in 1 BOTTLE (50228-363-05)Marketed from Dec 6, 2016
50228-363-30	5022803633050228036330	30 CAPSULE in 1 BOTTLE (50228-363-30)Marketed from Dec 6, 2016

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 and Sodium Bicarbonate
Generic name (nonproprietary): omeprazole and sodium bicarbonate
Active ingredients: Omeprazole — 20 mg/1Sodium bicarbonate — 1100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: ScieGen Pharmaceuticals, Inc.NDC labeler code 50228
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207476
Marketing start: Dec 6, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 50228-363_25403f99-6570-5b4b-e063-6294a90a9963SPL ID 25403f99-6570-5b4b-e063-6294a90a9963SPL set ID a107804e-b308-4e79-9447-07d93016f70fRxCUI 616539, 616541UNII KG60484QX9, 8MDF5V39QOUPC 0350228364300, 0350228363303
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

N450228036305 followed by a unit qualifier and the quantity

Package 50228-0363-05. 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 Oct 24, 2024.

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 used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of trea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50228-363

What is NDC 50228-363?: 50228-363 is the product NDC for Omeprazole and Sodium Bicarbonate, Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 capsule, listed with the FDA by ScieGen Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Omeprazole and Sodium Bicarbonate.
What is the active ingredient?: Omeprazole, Sodium bicarbonate.
Who is the labeler?: ScieGen Pharmaceuticals, Inc., NDC labeler code 50228. 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 and Sodium Bicarbonate?: 19 other product NDCs are listed under this name. See all Omeprazole and 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 and Sodium Bicarbonate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Omeprazole And Sodium Bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	Aurohealth LLC	58602-732	58602-0732-0558602-0732-5758602-0732-60
omeprazole and sodium bicarbonateomeprazole, sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	Amazon.com Services LLC	72288-564	72288-0564-03
Omeprazole and Sodium Bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1	Powder, For suspensionOral	ANI Pharmaceuticals, Inc.	70954-797	70954-0797-20
Omeprazole and Sodium Bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1680 mg/1	Powder, For suspensionOral	ANI Pharmaceuticals, Inc.	70954-798	70954-0798-20
Omeprazole and Sodium Bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	PHOENIX RX LLC	85509-1032	85509-1032-0185509-1032-0385509-1032-06
Omeprazole and Sodium Bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1	Powder, For suspensionOral	Dr. Reddy's Laboratories Inc.,	43598-010	43598-0010-0143598-0010-1443598-0010-28+1 more
Omeprazole and Sodium Bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1	Powder, For suspensionOral	Dr. Reddy's Laboratories Inc.,	43598-307	43598-0307-0143598-0307-1443598-0307-28+1 more
Omeprazole and Sodium Bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1	Powder, For suspensionOral	Dr. Reddy's Laboratories Inc.,	75907-138	75907-0138-42
Omeprazole And Sodium Bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	Aurohealth LLC	58602-725	58602-0725-0558602-0725-5758602-0725-60
omeprazole and sodium bicarbonateomeprazole, sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	Meijer Distribution Inc	41250-938	41250-0938-03

All 20 Omeprazole and Sodium Bicarbonate NDCs

Other NDCs under ANDA 207476

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

FDA NDC Directory listings under ANDA 207476
Product	Strength	Form · route	Labeler	Product NDC
Omeprazole and Sodium Bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-364
omeprazole sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	Cipla USA Inc.	69097-913
omeprazole sodium bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	Cipla USA Inc.	69097-914
Omeprazole/Bicarbonateomeprazole and sodium bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	Westminster Pharmaceuticals, LLC	69367-196
Omeprazole/Bicarbonateomeprazole and sodium bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	Proficient Rx LP	71205-985