Prescription drug · ANDA
Bupivacaine Spinal (Bupivacaine hydrochloride in dextrose) NDC 0409-3613
Bupivacaine hydrochloride 7.5 mg/mL · Injection, Solution · Subarachnoid · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-3613-01 | 0040936130100409361301 | 10 AMPULE in 1 CARTON (0409-3613-01) / 2 mL in 1 AMPULE (0409-3613-11)Marketed from Jan 31, 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 SpinalSuffix: Spinal
- Generic name (nonproprietary)
- bupivacaine hydrochloride in dextrose
- Active ingredients
- Bupivacaine hydrochloride — 7.5 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subarachnoid
- Labeler
- Hospira, Inc.NDC labeler code 0409
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071810
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 0409-3613_7a09a90d-26da-42bd-bb54-2d2102eb8c1cSPL ID 7a09a90d-26da-42bd-bb54-2d2102eb8c1cSPL set ID 7a8d2539-4422-4312-0298-207ef1a2948eRxCUI 1724784UNII 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
N400409361301followed by a unit qualifier and the quantityPackage 00409-3613-01. 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 .
Indications (excerpt from the label)
BUPIVACAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia). BUPIVACAINE SPINAL is an amide-local anesthetic indicated in adults for subarachnoid injection for the production of subarachnoid block (spinal anesthesia). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0409-3613
- What is NDC 0409-3613?
- 0409-3613 is the product NDC for Bupivacaine Spinal (bupivacaine hydrochloride in dextrose), Bupivacaine hydrochloride 7.5 mg/mL injection, solution, listed with the FDA by Hospira, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bupivacaine Spinal (Bupivacaine hydrochloride in dextrose).
- What is the active ingredient?
- Bupivacaine hydrochloride.
- 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 Spinal?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.