What is NDC 70594-121?

70594-121 is the product NDC for Bupivacine HCl (bupivacaine hydrochloride), Bupivacaine hydrochloride 7.5 mg/mL injection, solution, listed with the FDA by Xellia Pharmaceuticals USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Bupivacine HCl (Bupivacaine hydrochloride).

Xellia Pharmaceuticals USA LLC, NDC labeler code 70594. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Bupivacine HCl?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bupivacine HCl NDC 70594-121 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70594-121Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70594-0121Add 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
70594-121-01	7059401210170594012101	30 mL in 1 VIAL, SINGLE-DOSE (70594-121-01)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): Bupivacine HCl
Generic name (nonproprietary): bupivacaine hydrochloride
Active ingredients: Bupivacaine hydrochloride — 7.5 mg/mL
Dosage form: Injection, Solution
Route: Epidural, Intracaudal, Perineural
Labeler: Xellia Pharmaceuticals USA LLCNDC labeler code 70594
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091487
Marketing start: Jun 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 70594-121_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

N470594012101 followed by a unit qualifier and the quantity

Package 70594-0121-01. 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 Jun 9, 2023. 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)

About NDC 70594-121

What is NDC 70594-121?: 70594-121 is the product NDC for Bupivacine HCl (bupivacaine hydrochloride), Bupivacaine hydrochloride 7.5 mg/mL injection, solution, listed with the FDA by Xellia Pharmaceuticals USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Bupivacine HCl (Bupivacaine hydrochloride).
What is the active ingredient?: Bupivacaine hydrochloride.
Who is the labeler?: Xellia Pharmaceuticals USA LLC, NDC labeler code 70594. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Bupivacine HCl?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Product	Strength	Form · route	Labeler	Product NDC
Bupivacaine HClbupivacaine hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Intracaudal, Perineural	Xellia Pharmaceuticals USA LLC	70594-117
Bupivacaine HClbupivacaine hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Intracaudal, Perineural	Xellia Pharmaceuticals USA LLC	70594-118
Bupivacaine HClbupivacaine hydrochloride	Bupivacaine hydrochloride 7.5 mg/mL	Injection, SolutionEpidural, Intracaudal, Perineural	Xellia Pharmaceuticals USA LLC	70594-120
Bupivacaine HClbupivacaine hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Intracaudal, Perineural	Xellia Pharmaceuticals USA LLC	70594-114
BUPIVACAINE HClbupivacaine hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Intracaudal, Perineural	Xellia Pharmaceuticals USA LLC	70594-115
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration	ONESOURCE SPECIALTY PHARMA LIMITED	83270-162
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural	ONESOURCE SPECIALTY PHARMA LIMITED	83270-163
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 7.5 mg/mL	Injection, SolutionEpidural, Retrobulbar	ONESOURCE SPECIALTY PHARMA LIMITED	83270-164
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration	ONESOURCE SPECIALTY PHARMA LIMITED	83270-165
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural	ONESOURCE SPECIALTY PHARMA LIMITED	83270-166
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 7.5 mg/mL	Injection, SolutionEpidural, Retrobulbar	ONESOURCE SPECIALTY PHARMA LIMITED	83270-167
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration	Fosun Pharma USA Inc.	72266-263
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural	Fosun Pharma USA Inc.	72266-264

Bupivacine HCl (Bupivacaine hydrochloride) NDC 70594-121