NDC codes

FDA NDC Directory
Product NDC (as listed)57884-3252Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57884-3252Add 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
57884-3252-1578843252015788432520110 VIAL in 1 CARTON (57884-3252-1) / 20 mL in 1 VIALMarketed from Jul 1, 2024

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
Generic name (nonproprietary)
bupivacaine
Active ingredients
Bupivacaine — 13.3 mg/mL
Dosage form
Injection, Suspension, Liposomal
Route
Infiltration
Labeler
Jiangsu Hengrui Pharmaceuticals Co., Ltd.NDC labeler code 57884
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214348
Marketing start
Listing expires
Other FDA classes
Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers
Product ID 57884-3252_1c5d9dbb-0d16-6893-e063-6394a90ad989SPL ID 1c5d9dbb-0d16-6893-e063-6394a90ad989SPL set ID 0af296bb-1599-4b35-b66b-994924d3e898RxCUI 1191508, 1745061UNII Y8335394ROUPC 0357884325119, 0357884325218
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

N457884325201 followed by a unit qualifier and the quantity

Package 57884-3252-01. 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)

1. INDICATIONS AND USAGE Bupivacaine liposome injectable suspension is indicated to produce postsurgical: Local analgesia via infiltration in adults Regional analgesia via an interscalene brachial plexus nerve block in adults Limitations of Use The safety and effectiveness of bupivacaine liposome injectable suspension have not been established to produce postsurgical regional analgesia via other nerve blocks besides an interscalene brachial plexus nerve block. Bupivacaine liposome injectable suspension contains bupivacaine, an amide local anesthetic, and is indicated to produce postsurgical: Local analgesia via infiltration in adults ( 1 ). Regional analgesia via an interscalene brachial ple…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 57884-3252

What is NDC 57884-3252?
57884-3252 is the product NDC for Bupivacaine, Bupivacaine 13.3 mg/mL injection, suspension, liposomal, listed with the FDA by Jiangsu Hengrui Pharmaceuticals Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Bupivacaine.
What is the active ingredient?
Bupivacaine.
Who is the labeler?
Jiangsu Hengrui Pharmaceuticals Co., Ltd., NDC labeler code 57884. 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?
1 other product NDC are listed under this name. See all Bupivacaine 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
BupivacaineBupivacaine 13.3 mg/mLInjection, Suspension, LiposomalInfiltrationJiangsu Hengrui Pharmaceuticals Co., Ltd.57884-325157884-3251-01

Other NDCs under ANDA 214348

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

FDA NDC Directory listings under ANDA 214348
ProductStrengthForm · routeLabelerProduct NDC
BupivacaineBupivacaine 13.3 mg/mLInjection, Suspension, LiposomalInfiltrationJiangsu Hengrui Pharmaceuticals Co., Ltd.57884-3251

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