Prescription drug · ANDA
Omeprazole/Bicarbonate (Omeprazole and sodium bicarbonate) NDC 71205-985
Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 · Capsule, Gelatin coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-985-30 | 7120509853071205098530 | 30 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (71205-985-30)Marketed from May 1, 2020 | |
| 71205-985-60 | 7120509856071205098560 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (71205-985-60)Marketed from May 1, 2020 | |
| 71205-985-90 | 7120509859071205098590 | 90 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (71205-985-90)Marketed from May 1, 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/Bicarbonate
- Generic name (nonproprietary)
- omeprazole and sodium bicarbonate
- Active ingredients
- Omeprazole — 40 mg/1Sodium bicarbonate — 1100 mg/1
- Dosage form
- Capsule, Gelatin coated
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 71205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207476
- Marketing start
- Listing expires
- Other FDA classes
- Alkalinizing Activity (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Proton Pump Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-985_adaa81e9-047d-486e-aa53-d6cb4e931220SPL ID adaa81e9-047d-486e-aa53-d6cb4e931220SPL set ID 4d642036-7175-4f29-9f07-dbd282231d4aRxCUI 616539, 616541UNII KG60484QX9, 8MDF5V39QOUPC 0371205984601, 0371205985608
- 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
N471205098530followed by a unit qualifier and the quantityPackage 71205-0985-30. 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 is a proton pump inhibitor (PPI) indicated for: • Short-term treatment of active duodenal ulcer ( 1.1 ) • Short-term treatment of active benign gastric ulcer ( 1.2 ) • Treatment of gastroesophageal reflux disease (GERD) ( 1.3 ) • Maintenance of healing of erosive esophagitis ( 1.4 ) The safety and effectiveness of omeprazole and sodium bicarbonate capsules in pediatric patients (<18 years of age) have not been established. ( 8.4 ) 1.1 Duodenal Ulcer Omeprazole and sodium bicarbonate is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. [See Clinical…
Excerpt only. Read the full label for complete information.
About NDC 71205-985
- What is NDC 71205-985?
- 71205-985 is the product NDC for Omeprazole/Bicarbonate, Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 capsule, gelatin coated, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omeprazole/Bicarbonate (Omeprazole and Sodium Bicarbonate).
- What is the active ingredient?
- Omeprazole, Sodium bicarbonate.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 71205. 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/Bicarbonate?
- 1 other product NDC are listed under this name. See all Omeprazole/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/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/Bicarbonateomeprazole and sodium bicarbonate | Omeprazole 40 mg/1; Sodium bicarbonate 1100 mg/1 | Capsule, Gelatin coatedOral | Westminster Pharmaceuticals, LLC | 69367-196 | 69367-0196-30 |
Other NDCs under ANDA 207476
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 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 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 |