NDC codes

FDA NDC Directory
Product NDC (as listed)0409-3613Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00409-3613Add 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
0409-3613-01004093613010040936130110 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

N400409361301 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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