NDC codes

FDA NDC Directory
Product NDC (as listed)84549-259Labeler and product segments. Claims need a package NDC.
Product NDC at billing width84549-0259Add 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
84549-259-02845490259028454902590230 mL in 1 VIAL, SINGLE-DOSE (84549-259-02)Marketed from Oct 10, 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)
Bupivacaine Hydrochloride
Generic name (nonproprietary)
bupivacaine hydrochloride
Active ingredients
Bupivacaine hydrochloride — 2.5 mg/mL
Dosage form
Injection, Solution
Route
Epidural, Infiltration, Intracaudal, Perineural
Labeler
ProPharma DistributionNDC labeler code 84549
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 070583
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 84549-259_463f11a7-b3b6-3ab2-e063-6394a90a0449SPL ID 463f11a7-b3b6-3ab2-e063-6394a90a0449SPL set ID 3f7ab295-6429-4760-e063-6294a90a781fRxCUI 1012396UNII 7TQO7W3VT8
Pharmacologic class
Amide Local Anesthetic

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

N484549025902 followed by a unit qualifier and the quantity

Package 84549-0259-02. 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)

Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of Bupivacaine Hydrochloride Injection/Bupivacaine Hydrochloride and Epinephrine Injection are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. Bupivacaine Hydrochloride Injection contains bupivacaine, an amide local anesthetic, and Bupivacaine Hydrochloride and Epinephrine…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 84549-259

What is NDC 84549-259?
84549-259 is the product NDC for Bupivacaine Hydrochloride, Bupivacaine hydrochloride 2.5 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?
Bupivacaine Hydrochloride.
What is the active ingredient?
Bupivacaine 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 Bupivacaine Hydrochloride?
70 other product NDCs are listed under this name. See all Bupivacaine 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 Bupivacaine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralAnthea Pharma Private Limited83854-00483854-0004-1083854-0004-11
Bupivacaine HydrochlorideBupivacaine hydrochloride 7.5 mg/mLInjection, SolutionEpidural, RetrobulbarAnthea Pharma Private Limited83854-00583854-0005-1083854-0005-11
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionPerineuralAnthea Pharma Private Limited83854-00683854-0006-01
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Intracaudal, PerineuralAnthea Pharma Private Limited83854-03983854-0039-1083854-0039-11
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionInfiltration, PerineuralAnthea Pharma Private Limited83854-03883854-0038-01
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpiduralFosun Pharma USA Inc.72266-26472266-0264-10
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, InfiltrationFosun Pharma USA Inc.72266-26372266-0263-10
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, InfiltrationONESOURCE SPECIALTY PHARMA LIMITED83270-16283270-0162-10
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, InfiltrationONESOURCE SPECIALTY PHARMA LIMITED83270-16583270-0165-01
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpiduralONESOURCE SPECIALTY PHARMA LIMITED83270-16383270-0163-10

All 71 Bupivacaine Hydrochloride NDCs

Other NDCs under ANDA 070583

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

FDA NDC Directory listings under ANDA 070583
ProductStrengthForm · routeLabelerProduct NDC
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralHospira, Inc.0409-1159
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralCardinal Health 107, LLC55154-6970
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralSportpharm LLC85766-074
Bupivicaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralHF Acquisition Co LLC, DBA HealthFirst51662-1456

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