Prescription drug · ANDA
Bupivacaine Hydrochloride and Epinephrine NDC 0409-9042
Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate 5 ug/mL · Injection, Solution · Epidural, Infiltration, Intracaudal, Perineural · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-9042-01 | 0040990420100409904201 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-9042-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-9042-11)Marketed from Aug 26, 2005 | |
| 0409-9042-17 | 0040990421700409904217 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-9042-17) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-9042-16)Marketed from Mar 21, 2011 |
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
- Hospira, Inc.NDC labeler code 0409
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071165
- 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 0409-9042_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 30Q7KI53AK, 7TQO7W3VT8
- 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
N400409904201followed by a unit qualifier and the quantityPackage 00409-9042-01. 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.
About NDC 0409-9042
- What is NDC 0409-9042?
- 0409-9042 is the product NDC for Bupivacaine Hydrochloride and Epinephrine, Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate 5 ug/mL injection, solution, listed with the FDA by Hospira, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bupivacaine Hydrochloride and Epinephrine.
- What is the active ingredient?
- Bupivacaine hydrochloride, Epinephrine bitartrate.
- Who is the labeler?
- Hospira, Inc., NDC labeler code 0409. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bupivacaine Hydrochloride and Epinephrine?
- 3 other product NDCs are listed under this name. See all Bupivacaine Hydrochloride and Epinephrine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bupivacaine Hydrochloride and Epinephrine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bupivacaine Hydrochloride and Epinephrine | Bupivacaine hydrochloride 2.5 mg/mL; Epinephrine bitartrate 5 ug/mL | Injection, SolutionInfiltration, Perineural | Hospira, Inc. | 0409-9043 | 00409-9043-01 |
| Bupivacaine Hydrochloride and Epinephrine | Bupivacaine hydrochloride 5 mg/mL; Epinephrine bitartrate 5 ug/mL | Injection, SolutionPerineural | Hospira, Inc. | 0409-9046 | 00409-9046-01 |
| Bupivacaine Hydrochloride and Epinephrine | Bupivacaine hydrochloride 5 mg/mL; Epinephrine bitartrate 5 ug/mL | Injection, SolutionEpidural, Intracaudal, Perineural | Hospira, Inc. | 0409-9045 | 00409-9045-0100409-9045-17 |