FDA.reportPublic FDA data

Bupivacaine

Product NDC
57884-3251
11-digit product format
578843251
Labeler code
57884
Product ID
57884-3251_1c5d9dbb-0d16-6893-e063-6394a90ad989
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine
Dosage form
INJECTION, SUSPENSION, LIPOSOMAL
Route
INFILTRATION
Labeler
Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Application
ANDA214348
Marketing category
ANDA
Marketing start
2024-07-01
Substance
BUPIVACAINE
Active strength
13.3 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bupivacaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE13.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY8335394RO
Rxcui1191508, 1745061

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57884-3251-1Bupivacaine10 mL in 1 VIALINJECTION, SUSPENSION, LIPOSOMAL104
57884-3251-1Bupivacaine10 in 1 CARTONINJECTION, SUSPENSION, LIPOSOMAL104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57884-3251BUPIVACAINE INJECTION, SUSPENSION, LIPOSOMAL [JIANGSU HENGRUI PHARMACEUTICALS CO., LTD.]4Current NDC, 2 package rows20240711_0af296bb-1599-4b35-b66b-994924d3e898.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1745061BUPivacaine liposome 1.3 % in 10 ML InjectionPSN0af296bb-1599-4b35-b66b-994924d3e8984
1191508BUPivacaine liposome 1.3 % in 20 ML InjectionPSN0af296bb-1599-4b35-b66b-994924d3e8984
174506110 ML bupivacaine liposome 13.3 MG/ML InjectionSCD0af296bb-1599-4b35-b66b-994924d3e8984
119150820 ML bupivacaine liposome 13.3 MG/ML InjectionSCD0af296bb-1599-4b35-b66b-994924d3e8984
1191508bupivacaine liposome 1.3 % in 20 ML InjectionSY0af296bb-1599-4b35-b66b-994924d3e8984
1745061bupivacaine liposome 133 MG per 10 ML InjectionSY0af296bb-1599-4b35-b66b-994924d3e8984
1191508bupivacaine liposome 266 MG per 20 ML InjectionSY0af296bb-1599-4b35-b66b-994924d3e8984

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57884-3251-15788432510110 VIAL in 1 CARTON (57884-3251-1) / 10 mL in 1 VIAL10 vial2024-07-01NoNoCurrent