FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
0143-9331
11-digit product format
001439331
Labeler code
0143
Product ID
0143-9331_1f5e723d-d695-4460-8142-713a5d621cff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA204842
Marketing category
ANDA
Marketing start
2021-02-11
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
5 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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1724786, 1724787, 1724880, 1724884, 1725078, 1725082

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
0143-9331-01Bupivacaine Hydrochloride10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION104
0143-9331-10Bupivacaine Hydrochloride10 in 1 CARTONINJECTION, SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9331-01ML - Milliliter0143-93317d1b94ee-c044-4c87-8af6-84aa14877d1512021-11-09
0143-9331-10ML - Milliliter0143-9331b358b97c-0a01-4307-8e47-07f60a25228512021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9331BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20240413_8815c8c6-eed8-4afe-a5c1-44d2194025a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN8815c8c6-eed8-4afe-a5c1-44d2194025a34
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN8815c8c6-eed8-4afe-a5c1-44d2194025a34
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSN8815c8c6-eed8-4afe-a5c1-44d2194025a34
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSN8815c8c6-eed8-4afe-a5c1-44d2194025a34
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSN8815c8c6-eed8-4afe-a5c1-44d2194025a34
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSN8815c8c6-eed8-4afe-a5c1-44d2194025a34
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD8815c8c6-eed8-4afe-a5c1-44d2194025a34
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD8815c8c6-eed8-4afe-a5c1-44d2194025a34
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD8815c8c6-eed8-4afe-a5c1-44d2194025a34
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD8815c8c6-eed8-4afe-a5c1-44d2194025a34
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD8815c8c6-eed8-4afe-a5c1-44d2194025a34
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD8815c8c6-eed8-4afe-a5c1-44d2194025a34
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY8815c8c6-eed8-4afe-a5c1-44d2194025a34
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSY8815c8c6-eed8-4afe-a5c1-44d2194025a34
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSY8815c8c6-eed8-4afe-a5c1-44d2194025a34
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSY8815c8c6-eed8-4afe-a5c1-44d2194025a34
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSY8815c8c6-eed8-4afe-a5c1-44d2194025a34
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSY8815c8c6-eed8-4afe-a5c1-44d2194025a34
1724786bupivacaine HCl 225 MG per 30 ML InjectionSY8815c8c6-eed8-4afe-a5c1-44d2194025a34
1724787bupivacaine HCl 75 MG per 10 ML InjectionSY8815c8c6-eed8-4afe-a5c1-44d2194025a34
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSNf37a19ad-5e69-44a8-947b-847df2106fb31
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDf37a19ad-5e69-44a8-947b-847df2106fb31
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSYf37a19ad-5e69-44a8-947b-847df2106fb31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9331-010014393310110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
0143-9331-100014393311010 VIAL, SINGLE-DOSE in 1 CARTON (0143-9331-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0143-9331-01) 2021-02-110000-00-00NoNoCurrent