Prescription drug · ANDA
Omeprazole/Sodium Bicarbonate (Omeprazole) NDC 64380-182
Omeprazole 20 mg/1700mg; Sodium bicarbonate 1680 mg/1700mg · Powder, For suspension · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-182-02 | 6438001820264380018202 | 30 POUCH in 1 CARTON (64380-182-02) / 20 mg in 1 POUCH (64380-182-01)Marketed from Oct 1, 2022 |
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
- Active ingredients
- Omeprazole — 20 mg/1700mgSodium bicarbonate — 1680 mg/1700mg
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Strides Pharma Science LimitedNDC labeler code 64380
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079182
- Marketing start
- Listing expires
- Other FDA classes
- Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 64380-182_2ac68a93-2f3b-46aa-a874-c109ad1bfefeSPL ID 2ac68a93-2f3b-46aa-a874-c109ad1bfefeSPL set ID cf6d293e-d70d-443e-8292-d693e93aab55RxCUI 753557, 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
N464380018202followed by a unit qualifier and the quantityPackage 64380-0182-02. 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 .
Indications (excerpt from the label)
Omeprazole and sodium bicarbonate for oral suspension is 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 for oral suspension 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,…
Excerpt only. Read the full label for complete information.
About NDC 64380-182
- What is NDC 64380-182?
- 64380-182 is the product NDC for Omeprazole/Sodium Bicarbonate (omeprazole), Omeprazole 20 mg/1700mg; Sodium bicarbonate 1680 mg/1700mg powder, for suspension, listed with the FDA by Strides Pharma Science Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omeprazole/Sodium Bicarbonate (Omeprazole).
- What is the active ingredient?
- Omeprazole, Sodium bicarbonate.
- Who is the labeler?
- Strides Pharma Science Limited, NDC labeler code 64380. 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.
Related NDCs: other Omeprazole/Sodium Bicarbonate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 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 079182
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Omeprazole/Sodium Bicarbonateomeprazole | Omeprazole 40 mg/1720mg; Sodium bicarbonate 1680 mg/1720mg | Powder, For suspensionOral | Strides Pharma Science Limited | 64380-183 |