FDA.reportPublic FDA data

bupivacaine hydrochloride

Product NDC
71288-726
11-digit product format
712880726
Labeler code
71288
Product ID
71288-726_0949c302-51ce-4fc9-8b99-1df94e693718
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupivacaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
PERINEURAL
Labeler
Meitheal Pharmaceuticals Inc
Application
ANDA216039
Marketing category
ANDA
Marketing start
2023-06-23
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
Rxcui1012396, 1012404

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
71288-726-52bupivacaine hydrochloride50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION502
71288-726-52bupivacaine hydrochloride1 in 1 CARTONINJECTION, SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-726-52ML - Milliliter71288-726275164d7-0333-4f20-8fa9-7874a58bac1712023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-726BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC]2Current NDC, 2 package rows20230628_fe340f98-a0f3-446e-b281-47fd91c1e537.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSNfe340f98-a0f3-446e-b281-47fd91c1e5372
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSNfe340f98-a0f3-446e-b281-47fd91c1e5372
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCDfe340f98-a0f3-446e-b281-47fd91c1e5372
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCDfe340f98-a0f3-446e-b281-47fd91c1e5372
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSYfe340f98-a0f3-446e-b281-47fd91c1e5372
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSYfe340f98-a0f3-446e-b281-47fd91c1e5372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71288-726-52712880726521 VIAL, MULTI-DOSE in 1 CARTON (71288-726-52) / 50 mL in 1 VIAL, MULTI-DOSE2023-06-23NoNoHistorical