NDC codes

FDA NDC Directory
Product NDC (as listed)0409-1162Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00409-1162Add 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
0409-1162-01004091162010040911620125 VIAL, SINGLE-DOSE in 1 TRAY (0409-1162-01) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-1162-18)Marketed from Mar 8, 2006
0409-1162-02004091162020040911620225 VIAL, SINGLE-DOSE in 1 TRAY (0409-1162-02) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1162-19)Marketed from Nov 22, 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
Generic name (nonproprietary)
bupivacaine hydrochloride
Active ingredients
Bupivacaine hydrochloride — 5 mg/mL
Dosage form
Injection, Solution
Route
Epidural, Intracaudal, Perineural
Labeler
Hospira, Inc.NDC labeler code 0409
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 070584
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 0409-1162_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

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

N400409116201 followed by a unit qualifier and the quantity

Package 00409-1162-01. 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)

About NDC 0409-1162

What is NDC 0409-1162?
0409-1162 is the product NDC for Bupivacaine Hydrochloride, Bupivacaine hydrochloride 5 mg/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.
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 Hydrochloride?
70 other product NDCs are listed under this name. See all Bupivacaine Hydrochloride NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Bupivacaine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, Infiltration, Intracaudal, PerineuralAnthea Pharma Private Limited83854-00483854-0004-1083854-0004-11
Bupivacaine HydrochlorideBupivacaine hydrochloride 7.5 mg/mLInjection, SolutionEpidural, RetrobulbarAnthea Pharma Private Limited83854-00583854-0005-1083854-0005-11
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionPerineuralAnthea Pharma Private Limited83854-00683854-0006-01
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Intracaudal, PerineuralAnthea Pharma Private Limited83854-03983854-0039-1083854-0039-11
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionInfiltration, PerineuralAnthea Pharma Private Limited83854-03883854-0038-01
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpiduralFosun Pharma USA Inc.72266-26472266-0264-10
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, InfiltrationFosun Pharma USA Inc.72266-26372266-0263-10
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, InfiltrationONESOURCE SPECIALTY PHARMA LIMITED83270-16283270-0162-10
Bupivacaine HydrochlorideBupivacaine hydrochloride 2.5 mg/mLInjection, SolutionEpidural, InfiltrationONESOURCE SPECIALTY PHARMA LIMITED83270-16583270-0165-01
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpiduralONESOURCE SPECIALTY PHARMA LIMITED83270-16383270-0163-10

All 71 Bupivacaine Hydrochloride NDCs

Other NDCs under ANDA 070584

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 070584
ProductStrengthForm · routeLabelerProduct NDC
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Intracaudal, PerineuralAsclemed USA, Inc.76420-579
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Intracaudal, PerineuralProPharma Distribution84549-162
Bupivacaine HydrochlorideBupivacaine hydrochloride 5 mg/mLInjection, SolutionEpidural, Intracaudal, PerineuralSportpharm LLC85766-013

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