NDC codes

FDA NDC Directory
Product NDC (as listed)14789-900Labeler and product segments. Claims need a package NDC.
Product NDC at billing width14789-0900Add 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 NDC11-digit (billing)PackageCopy
14789-900-02147890900021478909000210 VIAL, MULTI-DOSE in 1 CARTON (14789-900-02) / 2 mL in 1 VIAL, MULTI-DOSEMarketed from Oct 14, 2007

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)
Procainamide Hydrochloride
Generic name (nonproprietary)
procainamide hydrochloride
Active ingredients
Procainamide hydrochloride — 500 mg/mL
Dosage form
Injection
Route
Intramuscular, Intravenous
Labeler
Nexus Pharmaceuticals LLCNDC labeler code 14789
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206332
Marketing start
Listing expires
Identifiers
Product ID 14789-900_44fbdf17-cfd1-0076-e063-6394a90abf0dSPL ID 44fbdf17-cfd1-0076-e063-6394a90abf0dSPL set ID d58751df-cd8b-45a6-8a32-af19e747e23aRxCUI 857886, 857962UNII SI4064O0LX
Pharmacologic class
Antiarrhythmic

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.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N414789090002 followed by a unit qualifier and the quantity

Package 14789-0900-02. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Procainamide hydrochloride injection is indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of procainamide, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of procainamide treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythm…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 14789-900

What is NDC 14789-900?
14789-900 is the product NDC for Procainamide Hydrochloride, Procainamide hydrochloride 500 mg/mL injection, listed with the FDA by Nexus Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Procainamide Hydrochloride.
What is the active ingredient?
Procainamide hydrochloride.
Who is the labeler?
Nexus Pharmaceuticals LLC, NDC labeler code 14789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Procainamide Hydrochloride?
14 other product NDCs are listed under this name. See all Procainamide Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Procainamide Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Procainamide HydrochlorideProcainamide hydrochloride 100 mg/mLInjection, SolutionIntramuscular, IntravenousCaplin Steriles Limited65145-15565145-0155-10
Procainamide HydrochlorideProcainamide hydrochloride 500 mg/mLInjection, SolutionIntramuscular, IntravenousCaplin Steriles Limited65145-15665145-0156-10
Procainamide HydrochlorideProcainamide hydrochloride 100 mg/mLInjection, SolutionIntramuscular, IntravenousSagent Pharmaceuticals25021-32225021-0322-10
Procainamide HydrochlorideProcainamide hydrochloride 500 mg/mLInjection, SolutionIntramuscular, IntravenousSagent Pharmaceuticals25021-32325021-0323-02
Procainamide HydrochlorideProcainamide hydrochloride 100 mg/mLInjection, SolutionIntramuscular, IntravenousMedical Purchasing Solutions, LLC.71872-735371872-7353-01
Procainamide HydrochlorideProcainamide hydrochloride 100 mg/mLInjectionIntramuscular, IntravenousREMEDYREPACK INC.70518-420870518-4208-00
Procainamide HydrochlorideProcainamide hydrochloride 100 mg/mLInjection, SolutionIntramuscular, IntravenousGland Pharma Limited68083-60368083-0603-25
Procainamide HydrochlorideProcainamide hydrochloride 500 mg/mLInjection, SolutionIntramuscular, IntravenousGland Pharma Limited68083-60468083-0604-25
Procainamide HydrochlorideProcainamide hydrochloride 100 mg/mLInjectionIntramuscular, IntravenousHF Acquisition Co LLC, DBA HealthFirst51662-163051662-1630-03
Procainamide HydrochlorideProcainamide hydrochloride 100 mg/mLInjectionIntramuscular, IntravenousInternational Medication Systems, Limited76329-339976329-3399-05

All 15 Procainamide Hydrochloride NDCs

Other NDCs under ANDA 206332

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 206332
ProductStrengthForm · routeLabelerProduct NDC
Procainamide HydrochlorideProcainamide hydrochloride 100 mg/mLInjectionIntramuscular, IntravenousNexus Pharmaceuticals LLC14789-901

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