Bupivacaine Hydrochloride NDC 51662-1396

NDC codes

FDA NDC Directory

Product NDC (as listed)51662-1396Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51662-1396Add 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
51662-1396-1	51662139601	50 mL in 1 VIAL, MULTI-DOSE (51662-1396-1)Marketed from Oct 16, 2019
51662-1396-3	51662139603	25 POUCH in 1 CASE (51662-1396-3) / 1 mL in 1 POUCH (51662-1396-2)Marketed from Oct 27, 2020

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Perineural
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 070597
Marketing start: Oct 16, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 51662-1396_1b5824c7-c46a-48c6-e063-6394a90a22ceSPL ID 1b5824c7-c46a-48c6-e063-6394a90a22ceSPL set ID 950d82b6-76a1-0c08-e053-2a95a90a3a92RxCUI 1012396, 1012404UNII 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

N451662139601 followed by a unit qualifier and the quantity

Package 51662-1396-01. 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 Jun 20, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE Bupivacaine Hydrochloride is indicated 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. Only the 0.25% and 0.5% concentrations are indicated for obstetrical anesthesia (See WARNINGS ). Experience with nonobstetrical surgical procedures in pregnant patients is not sufficient to recommend use of 0.75% concentration of Bupivacaine Hydrochloride in these patients. Bupivacaine Hydrochloride is not recommended for intravenous regional anesthesia (Bier Block) (See WARNINGS ). The routes of administration and indicated Bupivacaine Hydrochloride co…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 070597

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

FDA NDC Directory listings under ANDA 070597
Product	Strength	Form · route	Labeler	Product NDC
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionPerineural	Hospira, Inc.	0409-1163
Bupivacaine Hydrochloride	Bupivacaine hydrochloride 5 mg/mL	Injection, SolutionPerineural	Henry Schein, Inc	0404-9827