Home NDC 50090-4408-0 Polocaine
Product NDC 50090-4408
Requested package NDC 50090-4408-0
11-digit product format 500904408
Labeler code 50090
Product ID 50090-4408_edfa38ed-1cfa-4348-aec0-361de064d72b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MEPIVACAINE HYDROCHLORIDE
Dosage form INJECTION, SOLUTION
Route INFILTRATION
Labeler A-S Medication Solutions
Application ANDA089410
Marketing category ANDA
Marketing start 2009-07-20
Marketing end 0000-00-00
Substance MEPIVACAINE HYDROCHLORIDE
Active strength 20 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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 A089410-001 POLOCAINE MEPIVACAINE HYDROCHLORIDE 2% 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 · 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 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION RS 1986-12-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION RS 1986-12-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION RS 1986-12-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION 1986-12-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION 1986-12-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089410-001 POLOCAINE 2% INJECTABLE / INJECTION AP 1986-12-01 f41ea6bd6efb…
Observed Orange Book normalized TE history# FDA-Initiated Inactive NDC Indexing# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-4408-0 50090440800 1 VIAL, MULTI-DOSE in 1 BAG (50090-4408-0) > 50 mL in 1 VIAL, MULTI-DOSE 2019-07-02 0000-00-00 No No Current