What is NDC 0327-0012?

0327-0012 is the product NDC for Renacidin, Anhydrous citric acid 6.602 g/100mL + 2 more ingredients solution, listed with the FDA by United-Guardian, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Renacidin (Citric acid, gluconolactone and magnesium carbonate).

What is the active ingredient?

Anhydrous citric acid, Gluconolactone, Magnesium carbonate.

United-Guardian, Inc., NDC labeler code 0327. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Renacidin?

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.

Renacidin NDC 0327-0012 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0327-0012Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00327-0012Add 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	Copy
0327-0012-30	0032700123000327001230	30 BOTTLE in 1 CARTON (0327-0012-30) / 30 mL in 1 BOTTLEMarketed from Feb 1, 2016

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Renacidin
Generic name (nonproprietary): citric acid, gluconolactone and magnesium carbonate
Active ingredients: Anhydrous citric acid — 6.602 g/100mLGluconolactone — .198 g/100mLMagnesium carbonate — 3.268 g/100mL
Dosage form: Solution
Route: Irrigation
Labeler: United-Guardian, Inc.NDC labeler code 0327
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 019481
Marketing start: Feb 1, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)Irrigation (Mechanism)
Identifiers: Product ID 0327-0012_73bb8d15-8d5c-426c-b42f-504a5da9cb8eSPL ID 73bb8d15-8d5c-426c-b42f-504a5da9cb8eSPL set ID 13a9bbba-db21-4cba-991c-5d8afaf2ed74RxCUI 1792396, 1792398UNII XF417D3PSL, WQ29KQ9POT, 0E53J927NA
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400327001230 followed by a unit qualifier and the quantity

Package 00327-0012-30. 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 17, 2019.

Indications (excerpt from the label)

INDICATIONS AND USAGE Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. Renacidin is also indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0327-0012

What is NDC 0327-0012?: 0327-0012 is the product NDC for Renacidin, Anhydrous citric acid 6.602 g/100mL + 2 more ingredients solution, listed with the FDA by United-Guardian, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Renacidin (Citric acid, gluconolactone and magnesium carbonate).
What is the active ingredient?: Anhydrous citric acid, Gluconolactone, Magnesium carbonate.
Who is the labeler?: United-Guardian, Inc., NDC labeler code 0327. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Renacidin?: 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.