Bupivacaine Hydrochloride and Epinephrine NDC 0404-9828

NDC codes

FDA NDC Directory

Product NDC (as listed)0404-9828Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00404-9828Add 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
0404-9828-30	00404982830	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9828-30) / 30 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 9, 2022

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 and Epinephrine
Generic name (nonproprietary): bupivacaine hydrochloride and epinephrine
Active ingredients: Bupivacaine hydrochloride — 2.5 mg/mLEpinephrine bitartrate — 5 ug/mL
Dosage form: Injection, Solution
Route: Epidural, Infiltration, Intracaudal, Perineural
Labeler: Henry Schein, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 071165
Marketing start: Jan 9, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Amides (Chemical structure)Catecholamines (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 0404-9828_d06af667-46dd-4cf0-84fa-87e9be2d6d77SPL ID d06af667-46dd-4cf0-84fa-87e9be2d6d77SPL set ID a1a96ebb-31f2-43d5-8dd9-b0cc0d9cbd50RxCUI 1012377UNII 7TQO7W3VT8, 30Q7KI53AK
Pharmacologic class: Amide Local Anesthetic; Catecholamine; alpha-Adrenergic Agonist; beta-Adrenergic Agonist

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

N400404982830 followed by a unit qualifier and the quantity

Package 00404-9828-30. 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 Oct 27, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Indications and Usage Bupivacaine Hydrochloride is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia. (See WARNINGS .) Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of Bupivacaine Hydrochloride in these patients. Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia (Bier Block). (See WARNINGS .) The routes of administration and indicated Bupivacaine Hydrochlorid…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 071165

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

FDA NDC Directory listings under ANDA 071165
Product	Strength	Form · route	Labeler	Product NDC
Bupivacaine Hydrochloride and Epinephrine	Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate 5 ug/mL	Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural	Hospira, Inc.	0409-9042