Home NDC 51662-1534 POLOCAINE (MEPIVACAINE HCl)
Product NDC 51662-1534
11-digit product format 516621534
Labeler code 51662
Product ID 51662-1534_1034b916-15a5-44be-e063-6394a90a2c0b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name POLOCAINE (MEPIVACAINE HCl)
Dosage form INJECTION, SOLUTION
Route INFILTRATION
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application ANDA089407
Marketing category ANDA
Marketing start 2021-05-11
Substance MEPIVACAINE HYDROCHLORIDE
Active strength 10 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A089407-001 POLOCAINE MEPIVACAINE HYDROCHLORIDE 1% INJECTABLE / INJECTION RS 1986-12-01
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION RS 1986-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION 1986-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION 1986-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089407-001 POLOCAINE 1% INJECTABLE / INJECTION AP 1986-12-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base POLOCAINE (MEPIVACAINE HCl)
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEPIVACAINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4VFX2L7EM5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012722 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 51662-1534-2 POLOCAINE (MEPIVACAINE HCl) 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 3 51662-1534-2 POLOCAINE (MEPIVACAINE HCl) 1 in 1 POUCH INJECTION, SOLUTION 1 3 51662-1534-3 POLOCAINE (MEPIVACAINE HCl) 25 in 1 BOX INJECTION, SOLUTION 25 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1534 POLOCAINE (MEPIVACAINE HCL) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 3 Current NDC, Legacy NDC, 3 package rows 20240201_c21a4c3a-82c0-0bfb-e053-2995a90a2b65.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 Units Marketing start Marketing end Sample Exclude flag Status 51662-1534-2 51662153402 50 mL in 1 VIAL, MULTI-DOSE 50 ml Historical 51662-1534-3 51662153403 25 POUCH in 1 BOX (51662-1534-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1534-2) / 50 mL in 1 VIAL, MULTI-DOSE 25 pouch 2021-05-11 0000-00-00 No No Current