Home NDC 0404-9828 Bupivacaine Hydrochloride and Epinephrine
Product NDC 0404-9828
11-digit product format 004049828
Labeler code 0404
Product ID 0404-9828_d06af667-46dd-4cf0-84fa-87e9be2d6d77
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bupivacaine Hydrochloride and Epinephrine
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler Henry Schein, Inc.
Application ANDA071165
Marketing category ANDA
Marketing start 2022-01-09
Substance BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
Active strength 2.5; 5 mg/mL; ug/mL
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A071165-001 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE 0.25%;0.005MG/ML INJECTABLE / INJECTION RS 1988-06-16 f41ea6bd6efb…
Additional Listing Data#
Finished product Yes
Brand name base Bupivacaine Hydrochloride and Epinephrine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUPIVACAINE HYDROCHLORIDE 2.5 mg/mL EPINEPHRINE BITARTRATE 5 ug/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7TQO7W3VT8 Internal UNII lookup 30Q7KI53AK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012377 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0404-9828-30 Bupivacaine Hydrochloride and Epinephrine 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 5 0404-9828-30 Bupivacaine Hydrochloride and Epinephrine 1 in 1 BAG INJECTION, SOLUTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9828 BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, SOLUTION [HENRY SCHEIN, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20241016_a1a96ebb-31f2-43d5-8dd9-b0cc0d9cbd50.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0404-9828-30 00404982830 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9828-30) / 30 mL in 1 VIAL, SINGLE-DOSE 2022-01-09 0000-00-00 No No Current