Bupivacaine Hydrochloride NDC 0143-9328

NDC codes

FDA NDC Directory

Product NDC (as listed)0143-9328Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00143-9328Add 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
0143-9328-10	00143932810	10 VIAL, MULTI-DOSE in 1 CARTON (0143-9328-10) / 50 mL in 1 VIAL, MULTI-DOSE (0143-9328-01)Marketed from Feb 11, 2021

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Infiltration, Perineural
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205141
Marketing start: Feb 11, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 0143-9328_df5f611d-cfee-4378-9fc1-154b06ff68afSPL ID df5f611d-cfee-4378-9fc1-154b06ff68afSPL set ID 4595c642-1869-436c-9550-8f9f255efd27RxCUI 1012396, 1012404UNII 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

N400143932810 followed by a unit qualifier and the quantity

Package 00143-9328-10. 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 Apr 11, 2024. 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, dental 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) ]. Limitations of Use Not all blocks are indicated for use with Bupivacaine Hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration (2.2) , Contraindications (4) , Warnings and Precau…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 205141

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

FDA NDC Directory listings under ANDA 205141
Product	Strength	Form · route	Labeler	Product NDC
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionPerineural	Hikma Pharmaceuticals USA Inc.	0143-9329