Orange Book product
OMEPRAZOLE AND SODIUM BICARBONATE 20MG/PACKET;1.68GM/PACKET
Orange Book ANDA 219161 · NOVITIUM PHARMA LLC · Prescription
Key facts
| Proprietary name | OMEPRAZOLE AND SODIUM BICARBONATE |
|---|---|
| Active ingredients | OMEPRAZOLE, SODIUM BICARBONATE |
| Strength | 20MG/PACKET;1.68GM/PACKET |
| Dosage form | FOR SUSPENSION |
| Route | ORAL |
| Application | ANDA219161 |
| Applicant holder | NOVITIUM PHARMA LLC |
| Marketing status | Prescription |
| Therapeutic equivalence (TE) code | AB |
| Reference listed drug (RLD) | No |
| Reference standard (RS) | No |
| Approval date | Dec 10, 2025 |
At a glance
- 1–9 Marketed products with the same ingredient, strength and form
- 1–9 Products in this application
- No Reference listed drug
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Orange Book products
The FDA Orange Book lists approved drug products with their therapeutic equivalence (TE) codes, reference listed drugs and marketing status. Products approved before 1982 show an approval date of Jan 1, 1982.