Oracit
- Product NDC
- 46287-014
- 11-digit product format
- 462870014
- Labeler code
- 46287
- Product ID
- 46287-014_8691f6bc-18e9-4336-8e10-c702ecace00a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Citric Acid and Sodium Citrate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- CMP Pharma, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 1984-05-15
- Substance
- CITRIC ACID MONOHYDRATE; TRISODIUM CITRATE DIHYDRATE
- Active strength
- 640; 490 mg/5mL; mg/5mL
- Pharmacologic classes
- 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 Factor Activity [PE], Decreased Coagulation Factor Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oracit
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CITRIC ACID MONOHYDRATE | 640 mg/5mL |
| TRISODIUM CITRATE DIHYDRATE | 490 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2968PHW8QP, B22547B95K |
| Rxcui | 544550, 544553 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 46287-014-01 | Oracit | 500 mL in 1 BOTTLE | SOLUTION | 500 | | 5 |
| 46287-014-15 | Oracit | 15 mL in 1 BOTTLE, UNIT-DOSE | SOLUTION | 15 | | 5 |
| 46287-014-15 | Oracit | 10 in 1 CARTON | SOLUTION | 10 | | 5 |
| 46287-014-30 | Oracit | 30 mL in 1 BOTTLE, UNIT-DOSE | SOLUTION | 30 | | 5 |
| 46287-014-30 | Oracit | 10 in 1 CARTON | SOLUTION | 10 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46287-014 | ORACIT (CITRIC ACID AND SODIUM CITRATE) SOLUTION [CMP PHARMA, INC.] | 5 | Current NDC, Legacy NDC, 5 package rows | 20231208_bc26abed-8e6e-475d-8ab3-abf7d0377003.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 46287-014-01 | 46287001401 | 500 mL in 1 BOTTLE (46287-014-01) | 500 ml | 1984-05-15 | 0000-00-00 | No | No | Current |
| 46287-014-15 | 46287001415 | 10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-15) / 15 mL in 1 BOTTLE, UNIT-DOSE | | 1984-05-15 | 0000-00-00 | No | No | Current |
| 46287-014-30 | 46287001430 | 10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-30) / 30 mL in 1 BOTTLE, UNIT-DOSE | | 1984-05-15 | 0000-00-00 | No | No | Current |