What is NDC 43598-307?

43598-307 is the product NDC for Omeprazole and Sodium Bicarbonate, Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1 powder, for suspension, listed with the FDA by Dr. Reddy's Laboratories Inc.,. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Omeprazole, Sodium bicarbonate.

Dr. Reddy's Laboratories Inc.,, NDC labeler code 43598. 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 43598-307

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-307Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0307Add 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
43598-307-01	4359803070143598030701	1 PACKET in 1 CARTON (43598-307-01) / 1 POWDER, FOR SUSPENSION in 1 PACKETMarketed from Jul 15, 2024
43598-307-14	4359803071443598030714	14 PACKET in 1 CARTON (43598-307-14) / 1 POWDER, FOR SUSPENSION in 1 PACKETMarketed from Jul 15, 2024
43598-307-28	4359803072843598030728	28 PACKET in 1 CARTON (43598-307-28) / 1 POWDER, FOR SUSPENSION in 1 PACKETMarketed from Jul 15, 2024
43598-307-42	4359803074243598030742	42 PACKET in 1 CARTON (43598-307-42) / 1 POWDER, FOR SUSPENSION in 1 PACKETMarketed from Jul 15, 2024

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 — 1680 mg/1
Dosage form: Powder, For suspension
Route: Oral
Labeler: Dr. Reddy's Laboratories Inc.,NDC labeler code 43598
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217784
Marketing start: Jul 15, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
Identifiers: Product ID 43598-307_dc9f1708-68a6-cb89-36c5-4e5fdb30100eSPL ID dc9f1708-68a6-cb89-36c5-4e5fdb30100eSPL set ID c6b5f808-4a49-1303-9711-badb022ecd70RxCUI 753562UNII 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

N443598030701 followed by a unit qualifier and the quantity

Package 43598-0307-01. 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 Jul 19, 2023.

Indications (excerpt from the label)

Use(s) 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 43598-307

What is NDC 43598-307?: 43598-307 is the product NDC for Omeprazole and Sodium Bicarbonate, Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1 powder, for suspension, listed with the FDA by Dr. Reddy's Laboratories Inc.,. It has 4 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?: Dr. Reddy's Laboratories Inc.,, NDC labeler code 43598. 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.,	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
Omeprazole and sodium bicarbonateomeprazole, sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1100 mg/1	Capsule, Gelatin coatedOral	H E B	37808-732	37808-0732-0137808-0732-03

All 20 Omeprazole and Sodium Bicarbonate NDCs

Other NDCs under ANDA 217784

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

FDA NDC Directory listings under ANDA 217784
Product	Strength	Form · route	Labeler	Product NDC
Acid Reducer Powderomeprazole and sodium bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1	Powder, For suspensionOral	Dr. Reddy's Laboratories Inc.,	75907-237
Omeprazole and Sodium Bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1	Powder, For suspensionOral	Dr. Reddy's Laboratories Inc.,	43598-010
Omeprazole and Sodium Bicarbonate	Omeprazole 20 mg/1; Sodium bicarbonate 1680 mg/1	Powder, For suspensionOral	Dr. Reddy's Laboratories Inc.,	75907-138