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 | 00409904201 | 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 | 00409904217 | 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.
- 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 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
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.
Other NDCs under ANDA 071165
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| 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 | Henry Schein, Inc. | 0404-9828 |