What is NDC 84549-319?

84549-319 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 5 mg/mL injection, solution, listed with the FDA by ProPharma Distribution. It has 1 package NDC, shown above in 10- and 11-digit form.

ProPharma Distribution, NDC labeler code 84549. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Diltiazem Hydrochloride?

220 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diltiazem Hydrochloride NDC 84549-319 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)84549-319Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84549-0319Add 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
84549-319-05	84549031905	5 mL in 1 VIAL (84549-319-05)Marketed from Sep 18, 2025

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): Diltiazem Hydrochloride
Generic name (nonproprietary): diltiazem hydrochloride
Active ingredients: Diltiazem hydrochloride — 5 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: ProPharma DistributionNDC labeler code 84549
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074617
Marketing start: Jun 1, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 84549-319_3f2942d7-f4d1-2d77-e063-6294a90a74adSPL ID 3f2942d7-f4d1-2d77-e063-6294a90a74adSPL set ID 3f2942d7-f4d0-2d77-e063-6294a90a74adRxCUI 1791229UNII OLH94387TE
Pharmacologic class: Calcium Channel Blocker

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

N484549031905 followed by a unit qualifier and the quantity

Package 84549-0319-05. 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 Sep 18, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Diltiazem hydrochloride injection is indicated for the following: Atrial Fibrillation or Atrial Flutter Temporary control of rapid ventricular rate in atrial fibrillation or atrial flutter. It should not be used in patients with atrial fibrillation or atrial flutter associated with an accessory bypass tract such as in Wolff-Parkinson-White (WPW) syndrome or short PR syndrome. Paroxysmal Supraventricular Tachycardia Rapid conversion of paroxysmal supraventricular tachycardias (PSVT) to sinus rhythm. This includes AV nodal reentrant tachycardias and reciprocating tachycardias associated with an extranodal accessory pathway such as the WPW syndrome or short PR syndrome. Un…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 84549-319

What is NDC 84549-319?: 84549-319 is the product NDC for Diltiazem Hydrochloride, Diltiazem hydrochloride 5 mg/mL injection, solution, listed with the FDA by ProPharma Distribution. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Diltiazem Hydrochloride.
What is the active ingredient?: Diltiazem hydrochloride.
Who is the labeler?: ProPharma Distribution, NDC labeler code 84549. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Diltiazem Hydrochloride?: 220 other product NDCs are listed under this name. See all Diltiazem 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 Diltiazem Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Diltiazem hydrochloride	Diltiazem hydrochloride 90 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1931	70771-1931-0170771-1931-05
Diltiazem hydrochloride	Diltiazem hydrochloride 30 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1929	70771-1929-0170771-1929-05
Diltiazem hydrochloride	Diltiazem hydrochloride 60 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1930	70771-1930-0170771-1930-05
Diltiazem hydrochloride	Diltiazem hydrochloride 120 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1932	70771-1932-0170771-1932-05
Diltiazem hydrochloride	Diltiazem hydrochloride 60 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-200	72578-0200-0172578-0200-05
Diltiazem hydrochloride	Diltiazem hydrochloride 30 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-199	72578-0199-0172578-0199-05
Diltiazem hydrochloride	Diltiazem hydrochloride 90 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-201	72578-0201-0172578-0201-05
Diltiazem hydrochloride	Diltiazem hydrochloride 120 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-202	72578-0202-0172578-0202-05
Diltiazem Hydrochloride	Diltiazem hydrochloride 60 mg/1	Capsule, Extended releaseOral	Safecor Health LLC	48433-030	48433-0030-20
Diltiazem Hydrochloride	Diltiazem hydrochloride 90 mg/1	Capsule, Extended releaseOral	Safecor Health LLC	48433-031	48433-0031-20

All 221 Diltiazem Hydrochloride NDCs

Other NDCs under ANDA 074617

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

FDA NDC Directory listings under ANDA 074617
Product	Strength	Form · route	Labeler	Product NDC
Diltiazem Hydrochloride	Diltiazem hydrochloride 5 mg/mL	Injection, SolutionIntravenous	Medical Purchasing Solutions, LLC	71872-7345
Diltiazem Hydrochloride	Diltiazem hydrochloride 5 mg/mL	Injection, SolutionIntravenous	HF Acquisition Co. LLC DBA HealthFirst	51662-1712
Diltiazem Hydrochloride	Diltiazem hydrochloride 5 mg/mL	Injection, SolutionIntravenous	Sagent Pharmaceuticals	25021-319