Home NDC 63323-260 Polocaine-MPF
Product NDC 63323-260
11-digit product format 633230260
Labeler code 63323
Product ID 63323-260_b3d50315-0f09-4294-a788-990036dfc45c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MEPIVACAINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INFILTRATION
Labeler Fresenius Kabi USA, LLC
Application ANDA089406
Marketing category ANDA
Marketing start 2009-07-20
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 A089406-001 POLOCAINE-MPF 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 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION RS 1986-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION 1986-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION 1986-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A089406-001 POLOCAINE-MPF 1% INJECTABLE / INJECTION AP 1986-12-01 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Polocaine-MPF
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 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1012722 Internal RxNorm lookup 1012726 Internal RxNorm lookup 1012731 Internal RxNorm lookup 1012735 Internal RxNorm lookup 1012737 Internal RxNorm lookup 1012741 Internal RxNorm lookup 1866503 Internal RxNorm lookup 1866515 Internal RxNorm lookup 1866524 Internal RxNorm lookup 1866531 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 63323-260-01 Polocaine-MPF 30 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 30 5 63323-260-37 Polocaine-MPF 25 in 1 TRAY INJECTION, SOLUTION 25 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEPIVACAINE HYDROCHLORIDE ACTIVE INGREDIENT 4VFX2L7EM5 POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 2 MEPIVACAINE ACTIVE MOIETY B6E06QE59J POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 2 CALCIUM CHLORIDE INACTIVE INGREDIENT M4I0D6VV5M POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 2 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 2 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 2 POTASSIUM CHLORIDE INACTIVE INGREDIENT 660YQ98I10 POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 2 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 2 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-260 POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION POLOCAINE-MPF (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20221009_a27d0815-ae6b-4a21-a8f5-564c01e83814.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 63323-260-01 63323026001 30 mL in 1 VIAL, SINGLE-DOSE 30 ml Historical 63323-260-37 63323026037 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-260-37) / 30 mL in 1 VIAL, SINGLE-DOSE (63323-260-01) 2009-07-20 0000-00-00 No No Current