Prescription drug · ANDA

Bupivacaine HCl (bupivacaine hydrochloride) NDC 70594-117

Bupivacaine hydrochloride 5 mg/mL · Injection, Solution · Epidural, Intracaudal, Perineural · Xellia Pharmaceuticals USA LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)70594-117Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70594-0117Add 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
70594-117-027059401170210 VIAL in 1 CARTON (70594-117-02) / 10 mL in 1 VIAL (70594-117-01)Marketed from Jun 1, 2023

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 HCl
Generic name (nonproprietary)
bupivacaine hydrochloride
Active ingredients
Bupivacaine hydrochloride — 5 mg/mL
Dosage form
Injection, Solution
Route
Epidural, Intracaudal, Perineural
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091487
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 70594-117_afc179ac-71b9-4021-8b71-3372bf590e4aSPL ID afc179ac-71b9-4021-8b71-3372bf590e4aSPL set ID f29c905e-9a55-446f-a89d-860ad9ade7adRxCUI 1724786, 1724787, 1724880, 1724884, 1725078, 1725082UNII 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

N470594011702 followed by a unit qualifier and the quantity

Package 70594-0117-02. 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 is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures. Specific concentrations and presentations of bupivacaine hydrochloride 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. Bupivacaine hydrochloride injection is indicated in adults for the production of local or regional anesthesia or analgesia for surgery and oral surgery proce…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 091487

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

FDA NDC Directory listings under ANDA 091487
ProductStrengthForm · routeLabelerProduct NDC
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, InfiltrationFosun Pharma USA Inc.72266-263
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpiduralFosun Pharma USA Inc.72266-264
Bupivacaine HClbupivacaine hydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, Intracaudal, PerineuralXellia Pharmaceuticals USA LLC70594-114
BUPIVACAINE HClbupivacaine hydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, Intracaudal, PerineuralXellia Pharmaceuticals USA LLC70594-115
Bupivacaine HClbupivacaine hydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Intracaudal, PerineuralXellia Pharmaceuticals USA LLC70594-118
Bupivacaine HClbupivacaine hydrochlorideBupivacaine hydrochloride 7.5 mg/mLInjection, SolutionEpidural, Intracaudal, PerineuralXellia Pharmaceuticals USA LLC70594-120
Bupivacine HClbupivacaine hydrochlorideBupivacaine hydrochloride 7.5 mg/mLInjection, SolutionEpidural, Intracaudal, PerineuralXellia Pharmaceuticals USA LLC70594-121
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, InfiltrationONESOURCE SPECIALTY PHARMA LIMITED83270-162
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpiduralONESOURCE SPECIALTY PHARMA LIMITED83270-163
Bupivacaine HydrochlorideBupivacaine hydrochloride 7.5 mg/mLInjection, SolutionEpidural, RetrobulbarONESOURCE SPECIALTY PHARMA LIMITED83270-164
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, InfiltrationONESOURCE SPECIALTY PHARMA LIMITED83270-165
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpiduralONESOURCE SPECIALTY PHARMA LIMITED83270-166
Bupivacaine HydrochlorideBupivacaine hydrochloride 7.5 mg/mLInjection, SolutionEpidural, RetrobulbarONESOURCE SPECIALTY PHARMA LIMITED83270-167

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