Polocaine

Product NDC: 50090-4517
Requested package NDC: 50090-4517-0
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-4517	50090-4517-0	I	Inactivated by FDA		2026-08-10

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 · 15 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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089407-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089407-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089407-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089407-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089407-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089407-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089407-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089407-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089407-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089407-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089407-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089407-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089407-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089407-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089407-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089407-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089407-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089407-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089407-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089407-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089407-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089407-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089407-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089407-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089407-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089407-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089407-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089407-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089407-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089407-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089407-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089407-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089407-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089407-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089407-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089407-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089407-001	AP	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2a6327eb-55be-3f7d-6c02-d7451033ded4	Product name	1	20140508
c9232c8e-ce6a-0381-9a9f-9f12074ca339	Product name	1	20140508
d6039924-e573-fcdd-4fd1-ec85172a4599	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-4517-0	2023-01-30	C162847	48780-1	f386c649-d14a-0266-e053-dadaa90a7c1a	POLOCAINE® (Mepivacaine Hydrochloride Injection, USP) POLOCAINE®-MPF (Mepivacaine Hydrochloride Injection, USP)

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4517-0	ML - Milliliter	50090-4517	8be362a0-d3b8-4130-bf04-4a4ae05fb30c	1	2022-07-06

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POLOCAINE (MEPIVACAINE HCl)	POLOCAINE (MEPIVACAINE HCL)	HF Acquisition Co LLC, DBA HealthFirst	c21a4c3a-82c0-0bfb-e053-2995a90a2b65	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089407 application number: ANDA089407
Polocaine-MPF	MEPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	a27d0815-ae6b-4a21-a8f5-564c01e83814	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089407 application number: ANDA089407

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4VFX2L7EM5	MEPIVACAINE HYDROCHLORIDE	1722-62-9	MEPIVACAINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1012722	mepivacaine HCl 1 % Injectable Solution	PSN	643a8a85-e7c6-4f09-a179-0a8e63de1bac	4
1012726	Polocaine 1 % Injectable Solution	PSN	643a8a85-e7c6-4f09-a179-0a8e63de1bac	4
1012726	mepivacaine hydrochloride 10 MG/ML Injectable Solution [Polocaine]	SBD	643a8a85-e7c6-4f09-a179-0a8e63de1bac	4
1012722	mepivacaine hydrochloride 10 MG/ML Injectable Solution	SCD	643a8a85-e7c6-4f09-a179-0a8e63de1bac	4
1012722	mepivacaine hydrochloride 1 % Injectable Solution	SY	643a8a85-e7c6-4f09-a179-0a8e63de1bac	4
1012726	Polocaine 1 % Injectable Solution	SY	643a8a85-e7c6-4f09-a179-0a8e63de1bac	4
1012726	Polocaine 10 MG/ML Injectable Solution	SY	643a8a85-e7c6-4f09-a179-0a8e63de1bac	4

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POLOCAINE® (Mepivacaine Hydrochloride Injection, USP) POLOCAINE®-MPF (Mepivacaine Hydrochloride Injection, USP)	A-S Medication Solutions	2020-07-13	HUMAN PRESCRIPTION DRUG LABEL	4