What is NDC 69097-913?

69097-913 is the product NDC for omeprazole sodium bicarbonate, Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 capsule, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Cipla USA Inc., NDC labeler code 69097. 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 69097-913

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-913Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0913Add 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
69097-913-02	6909709130269097091302	30 CAPSULE in 1 BOTTLE (69097-913-02)Marketed from Jan 30, 2017
69097-913-12	6909709131269097091312	500 CAPSULE in 1 BOTTLE (69097-913-12)Marketed from Jan 30, 2017

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: Cipla USA Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207476
Marketing start: Jan 30, 2017
Listing expires: Dec 31, 2027
Other FDA classes: Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 69097-913_d7eae0fc-9dfd-48d5-9491-e785fd66d5ecSPL ID d7eae0fc-9dfd-48d5-9491-e785fd66d5ecSPL set ID 9cdde58a-ae8a-451f-92cf-cab178e4ba92RxCUI 616539, 616541UNII KG60484QX9, 8MDF5V39QOUPC 0369097914028, 0369097913021
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

N469097091302 followed by a unit qualifier and the quantity

Package 69097-0913-02. 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 1, 2023.

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 69097-913

What is NDC 69097-913?: 69097-913 is the product NDC for omeprazole sodium bicarbonate, Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1 capsule, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, 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?: Cipla USA Inc., NDC labeler code 69097. 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	Guardian Drug Company	53041-664	53041-0664-77
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 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 20 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-363
Omeprazole and Sodium Bicarbonate	Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1	CapsuleOral	ScieGen Pharmaceuticals, Inc.	50228-364
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