What is NDC 46287-014?

46287-014 is the product NDC for Oracit, Citric acid monohydrate 640 mg/5mL; Trisodium citrate dihydrate 490 mg/5mL solution, listed with the FDA by CMP Pharma, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Oracit (Citric Acid and Sodium Citrate).

What is the active ingredient?

Citric acid monohydrate, Trisodium citrate dihydrate.

CMP Pharma, Inc., NDC labeler code 46287. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Oracit?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Oracit NDC 46287-014 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46287-014Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46287-0014Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
46287-014-01	4628700140146287001401	500 mL in 1 BOTTLE (46287-014-01)Marketed from May 15, 1984
46287-014-15	4628700141546287001415	10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-15) / 15 mL in 1 BOTTLE, UNIT-DOSEMarketed from May 15, 1984
46287-014-30	4628700143046287001430	10 BOTTLE, UNIT-DOSE in 1 CARTON (46287-014-30) / 30 mL in 1 BOTTLE, UNIT-DOSEMarketed from May 15, 1984

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): Oracit
Generic name (nonproprietary): citric acid and sodium citrate
Active ingredients: Citric acid monohydrate — 640 mg/5mLTrisodium citrate dihydrate — 490 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: CMP Pharma, Inc.NDC labeler code 46287
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: May 15, 1984
Listing expires: Dec 31, 2026
Other FDA classes: Acidifying Activity (Mechanism)Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)Decreased Coagulation Factor Activity (Physiologic effect)
Identifiers: Product ID 46287-014_8691f6bc-18e9-4336-8e10-c702ecace00aSPL ID 8691f6bc-18e9-4336-8e10-c702ecace00aSPL set ID bc26abed-8e6e-475d-8ab3-abf7d0377003RxCUI 544550, 544553UNII 2968PHW8QP, B22547B95KUPC 0346287014010
Pharmacologic class: Anti-coagulant; Calculi Dissolution Agent

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

N446287001401 followed by a unit qualifier and the quantity

Package 46287-0014-01. 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 Dec 7, 2023.

Indications (excerpt from the label)

INDICATIONS ORACIT ® is indicated for the treatment of metabolic acidosis. This solution is also useful in conditions where long term maintenance of alkaline urine is needed (e.g. uric acid and cystine calculi of the urinary tract). ORACIT ® is also effective in treatment for acidosis of certain renal tubular disorders.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46287-014

What is NDC 46287-014?: 46287-014 is the product NDC for Oracit, Citric acid monohydrate 640 mg/5mL; Trisodium citrate dihydrate 490 mg/5mL solution, listed with the FDA by CMP Pharma, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Oracit (Citric Acid and Sodium Citrate).
What is the active ingredient?: Citric acid monohydrate, Trisodium citrate dihydrate.
Who is the labeler?: CMP Pharma, Inc., NDC labeler code 46287. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Oracit?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Oracit (Citric acid and sodium citrate) NDC 46287-014