BUPIVACAINE HCI

Product NDC
51662-1581
11-digit product format
516621581
Labeler code
51662
Product ID
51662-1581_0f90b497-04bc-5195-e063-6294a90a2b58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HCI
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA207183
Marketing category
ANDA
Marketing start
2022-07-10
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
2.5 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 HCI
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1012396

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
51662-1581-2BUPIVACAINE HCI1 in 1 POUCHINJECTION, SOLUTION12
51662-1581-2BUPIVACAINE HCI50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION502
51662-1581-3BUPIVACAINE HCI25 in 1 CASEINJECTION, SOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1581BUPIVACAINE HCI INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 3 package rows20240123_e37e1599-db88-2fcd-e053-2995a90a00e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSNe37e1599-db88-2fcd-e053-2995a90a00e52
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCDe37e1599-db88-2fcd-e053-2995a90a00e52
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSYe37e1599-db88-2fcd-e053-2995a90a00e52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1581-2516621581021 in 1 POUCHHistorical
51662-1581-35166215810325 POUCH in 1 CASE (51662-1581-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1581-2) / 50 mL in 1 VIAL, MULTI-DOSE25 pouch2022-07-100000-00-00NoNoCurrent