What is NDC 76420-561?

76420-561 is the product NDC for Bupivacaine Hydrochloride, Bupivacaine hydrochloride 5 mg/mL injection, solution, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Asclemed USA, Inc., NDC labeler code 76420. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bupivacaine Hydrochloride NDC 76420-561

NDC codes

FDA NDC Directory

Product NDC (as listed)76420-561Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76420-0561Add 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 NDC	11-digit (billing)	Package	Copy
76420-561-10	7642005611076420056110	10 mL in 1 VIAL, SINGLE-DOSE (76420-561-10)Marketed from Aug 10, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Asclemed USA, Inc.NDC labeler code 76420
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204842
Marketing start: Feb 11, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 76420-561_028b204a-e3a0-ea94-e063-6294a90ad70eSPL ID 028b204a-e3a0-ea94-e063-6294a90ad70eSPL set ID f37a19ad-5e69-44a8-947b-847df2106fb3RxCUI 1724880UNII 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

N476420056110 followed by a unit qualifier and the quantity

Package 76420-0561-10. 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 Aug 10, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Bupivacaine Hydrochloride 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 are recommended for each type of block indicated to produce local or regional anesthesia or analgesia [see Dosage and Administration (2.2) ]. Limitations of Use Not all blocks are indicated for use with Bupivacaine Hydrochloride injection given clinically significant risks associated with use [see Dosage and Administration (2.2) , Contraindications (4) , Warnings and Precau…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-561

What is NDC 76420-561?: 76420-561 is the product NDC for Bupivacaine Hydrochloride, Bupivacaine hydrochloride 5 mg/mL injection, solution, listed with the FDA by Asclemed USA, Inc.. It has 1 package NDC, 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?: Asclemed USA, Inc., NDC labeler code 76420. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural	Anthea Pharma Private Limited	83854-004	83854-0004-1083854-0004-11
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 7.5 mg/mL	Injection, SolutionEpidural, Retrobulbar	Anthea Pharma Private Limited	83854-005	83854-0005-1083854-0005-11
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionPerineural	Anthea Pharma Private Limited	83854-006	83854-0006-01
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Intracaudal, Perineural	Anthea Pharma Private Limited	83854-039	83854-0039-1083854-0039-11
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionInfiltration, Perineural	Anthea Pharma Private Limited	83854-038	83854-0038-01
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural	Fosun Pharma USA Inc.	72266-264	72266-0264-10
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration	Fosun Pharma USA Inc.	72266-263	72266-0263-10
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration	ONESOURCE SPECIALTY PHARMA LIMITED	83270-162	83270-0162-10
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration	ONESOURCE SPECIALTY PHARMA LIMITED	83270-165	83270-0165-01
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural	ONESOURCE SPECIALTY PHARMA LIMITED	83270-163	83270-0163-10

All 71 Bupivacaine Hydrochloride NDCs

Other NDCs under ANDA 204842

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

FDA NDC Directory listings under ANDA 204842
Product	Strength	Form · route	Labeler	Product NDC
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural	Hikma Pharmaceuticals USA Inc.	0143-9330
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Intracaudal, Perineural	Hikma Pharmaceuticals USA Inc.	0143-9331
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 7.5 mg/mL	Injection, SolutionEpidural, Retrobulbar	Hikma Pharmaceuticals USA Inc.	0143-9332
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 2.5 mg/mL	Injection, SolutionEpidural, Infiltration, Intracaudal, Perineural	Hikma Pharmaceuticals USA Inc.	0143-9333
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionEpidural, Intracaudal, Perineural	Hikma Pharmaceuticals USA Inc.	0143-9334
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 7.5 mg/mL	Injection, SolutionEpidural, Retrobulbar	Hikma Pharmaceuticals USA Inc.	0143-9335