oracit

Generic: citric acid and sodium citrate

Labeler: cmp pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name oracit
Generic Name citric acid and sodium citrate
Labeler cmp pharma, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

citric acid monohydrate 640 mg/5mL, trisodium citrate dihydrate 490 mg/5mL

Manufacturer
CMP Pharma, Inc.

Identifiers & Regulatory

Product NDC 46287-014
Product ID 46287-014_8691f6bc-18e9-4336-8e10-c702ecace00a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 1984-05-15

Pharmacologic Class

Classes
acidifying activity [moa] anti-coagulant [epc] calcium chelating activity [moa] calculi dissolution agent [epc] decreased coagulation factor activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46287014
Hyphenated Format 46287-014

Supplemental Identifiers

RxCUI
544550 544553
UPC
0346287014010
UNII
2968PHW8QP B22547B95K

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name oracit (source: ndc)
Generic Name citric acid and sodium citrate (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 640 mg/5mL
  • 490 mg/5mL
source: ndc
Packaging
  • 500 mL in 1 BOTTLE (46287-014-01)
  • 10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-15) / 15 mL in 1 BOTTLE, UNIT-DOSE
  • 10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-30) / 30 mL in 1 BOTTLE, UNIT-DOSE
source: ndc

Packages (3)

46287-014-01 500 mL in 1 BOTTLE (46287-014-01) 46287-014-15 10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-15) / 15 mL in 1 BOTTLE, UNIT-DOSE 46287-014-30 10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-30) / 30 mL in 1 BOTTLE, UNIT-DOSE

Ingredients (2)

citric acid monohydrate (640 mg/5mL) trisodium citrate dihydrate (490 mg/5mL)

Linked Drug Pages (1)

Oracit ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8691f6bc-18e9-4336-8e10-c702ecace00a", "openfda": {"upc": ["0346287014010"], "unii": ["2968PHW8QP", "B22547B95K"], "rxcui": ["544550", "544553"], "spl_set_id": ["bc26abed-8e6e-475d-8ab3-abf7d0377003"], "manufacturer_name": ["CMP Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 mL in 1 BOTTLE (46287-014-01)", "package_ndc": "46287-014-01", "marketing_start_date": "19840515"}, {"sample": false, "description": "10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-15)  / 15 mL in 1 BOTTLE, UNIT-DOSE", "package_ndc": "46287-014-15", "marketing_start_date": "19840515"}, {"sample": false, "description": "10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-30)  / 30 mL in 1 BOTTLE, UNIT-DOSE", "package_ndc": "46287-014-30", "marketing_start_date": "19840515"}], "brand_name": "Oracit", "product_id": "46287-014_8691f6bc-18e9-4336-8e10-c702ecace00a", "dosage_form": "SOLUTION", "pharm_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 Factor Activity [PE]", "Decreased Coagulation Factor Activity [PE]"], "product_ndc": "46287-014", "generic_name": "Citric Acid and Sodium Citrate", "labeler_name": "CMP Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oracit", "active_ingredients": [{"name": "CITRIC ACID MONOHYDRATE", "strength": "640 mg/5mL"}, {"name": "TRISODIUM CITRATE DIHYDRATE", "strength": "490 mg/5mL"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "19840515", "listing_expiration_date": "20261231"}