Home NDC 50090-4517 Polocaine
Product NDC 50090-4517
11-digit product format 500904517
Labeler code 50090
Product ID 50090-4517_1960a2b0-b70c-403b-aeab-ba52ac15ae13
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MEPIVACAINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INFILTRATION
Labeler A-S Medication Solutions
Application ANDA089407
Marketing category ANDA
Marketing start 2009-07-20
Marketing end 0000-00-00
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 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-4517-0 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-4517-0 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50090-4517-0 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50090-4517-0 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50090-4517-0 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50090-4517-0 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50090-4517-0 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50090-4517-0 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50090-4517-0 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50090-4517-0 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50090-4517-0 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50090-4517-0 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50090-4517-0 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50090-4517-0 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50090-4517-0 1332a3947898…d4bfe170f9cd…
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# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-4517-0 Polocaine 50 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 50 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4517 POLOCAINE (MEPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [A-S MEDICATION SOLUTIONS] 4 Legacy NDC, 1 package rows 20200714_643a8a85-e7c6-4f09-a179-0a8e63de1bac.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 50090-4517-0 50090451700 50 mL in 1 VIAL, MULTI-DOSE (50090-4517-0) 50 ml 2019-09-11 0000-00-00 No No Current