NDC codes

FDA NDC Directory
Product NDC (as listed)0409-9046Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00409-9046Add 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
0409-9046-010040990460125 CARTON in 1 BOX (0409-9046-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-9046-11) / 50 mL in 1 VIAL, MULTI-DOSEMarketed from Jul 26, 2005

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 hydrochloride5 mg/mLEpinephrine bitartrate5 ug/mL
Dosage form
Injection, Solution
Route
Perineural
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 071170
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha-Agonists (Mechanism)Adrenergic beta-Agonists (Mechanism)Amides (Chemical structure)Catecholamines (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 0409-9046_6e442bfd-d3da-4913-8585-ce3485644364SPL ID 6e442bfd-d3da-4913-8585-ce3485644364SPL set ID 02a845c3-4521-4926-e397-25ab536e7cf6RxCUI 1012377, 1012384, 1012396, 1012404, 1672917, 1672919, 1724786, 1724787, 1724880, 1724884, 1725078, 1725082, 1867594, 1867596UNII 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

N400409904601 followed by a unit qualifier and the quantity

Package 00409-9046-01. 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 . 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)

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in