NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1630Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1630Add 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
51662-1630-351662163003516621630035 POUCH in 1 CASE (51662-1630-3) / 1 BOX in 1 POUCH (51662-1630-2) / 1 SYRINGE in 1 BOX / 10 mL in 1 SYRINGE (51662-1630-1)Marketed from Jun 23, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 100 mg/mL
Dosage form
Injection
Route
Intramuscular, Intravenous
Labeler
HF Acquisition Co LLC, DBA HealthFirstNDC labeler code 51662
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 088636
Marketing start
Listing expires
Identifiers
Product ID 51662-1630_54a2bc8f-12bf-562b-e063-6394a90a28e2SPL ID 54a2bc8f-12bf-562b-e063-6394a90a28e2SPL set ID fece65c0-fdbc-61d8-e053-6294a90a9a68RxCUI 1862220UNII 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

N451662163003 followed by a unit qualifier and the quantity

Package 51662-1630-03. 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 & 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 arrhythmia…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51662-1630

What is NDC 51662-1630?
51662-1630 is the product NDC for Procainamide Hydrochloride, Procainamide hydrochloride 100 mg/mL injection, listed with the FDA by HF Acquisition Co LLC, DBA HealthFirst. 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?
HF Acquisition Co LLC, DBA HealthFirst, NDC labeler code 51662. 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, IntravenousInternational Medication Systems, Limited76329-339976329-3399-05
Procainamide HydrochlorideProcainamide hydrochloride 100 mg/mLInjectionIntramuscular, IntravenousProPharma Distribution84549-39984549-0399-05

All 15 Procainamide Hydrochloride NDCs

Other NDCs under ANDA 088636

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

FDA NDC Directory listings under ANDA 088636
ProductStrengthForm · routeLabelerProduct NDC
Procainamide HydrochlorideProcainamide hydrochloride 100 mg/mLInjectionIntramuscular, IntravenousREMEDYREPACK INC.70518-4208
Procainamide HydrochlorideProcainamide hydrochloride 100 mg/mLInjectionIntramuscular, IntravenousInternational Medication Systems, Limited76329-3399
Procainamide HydrochlorideProcainamide hydrochloride 100 mg/mLInjectionIntramuscular, IntravenousProPharma Distribution84549-399

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