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NDC 46287-0014-01 Oracit 640; 490 mg/5mL; mg/5mL Details
Oracit 640; 490 mg/5mL; mg/5mL
Oracit is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by CMP Pharma, Inc.. The primary component is CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE.
Product Information
| NDC | 46287-0014 |
|---|---|
| Product ID | 46287-014_8691f6bc-18e9-4336-8e10-c702ecace00a |
| Associated GPIs | 56202020002020 |
| GCN Sequence Number | 043911 |
| GCN Sequence Number Description | citric acid/sodium citrate SOLUTION 640-490MG ORAL |
| HIC3 | R1S |
| HIC3 Description | URINARY PH MODIFIERS |
| GCN | 51959 |
| HICL Sequence Number | 003682 |
| HICL Sequence Number Description | CITRIC ACID/SODIUM CITRATE |
| Brand/Generic | Brand |
| Proprietary Name | Oracit |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Citric Acid and Sodium Citrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 640; 490 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE |
| Labeler Name | CMP Pharma, Inc. |
| Pharmaceutical Class | Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation F |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
NDC 46287-0014-01 (46287001401)
| NDC Package Code | 46287-014-01 |
|---|---|
| Billing NDC | 46287001401 |
| Package | 500 mL in 1 BOTTLE (46287-014-01) |
| Marketing Start Date | 1984-05-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |