POLOCAINE(R) -MPF (MEPIVACAINE HCI)

Product NDC: 51662-1403
11-digit product format: 516621403
Labeler code: 51662
Product ID: 51662-1403_101eb629-ce5c-2499-e063-6394a90ad55c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: POLOCAINE(R) -MPF (MEPIVACAINE HCI)
Dosage form: INJECTION, SOLUTION
Route: EPIDURAL; INFILTRATION
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA089406
Marketing category: ANDA
Marketing start: 2019-12-10
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#

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	A089406-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089406-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089406-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089406-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089406-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089406-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089406-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089406-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089406-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089406-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089406-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089406-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089406-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089406-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089406-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089406-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089406-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089406-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089406-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089406-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089406-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089406-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089406-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089406-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089406-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089406-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089406-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089406-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089406-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089406-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089406-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089406-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089406-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089406-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089406-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089406-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089406-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: POLOCAINE(R) -MPF (MEPIVACAINE HCI)
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
1866503	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
996381e2-485b-9434-e053-2a95a90a08e1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
2a6327eb-55be-3f7d-6c02-d7451033ded4	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
c9232c8e-ce6a-0381-9a9f-9f12074ca339	Product name	1	20140508
d6039924-e573-fcdd-4fd1-ec85172a4599	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51662-1403-1	POLOCAINE(R) -MPF (MEPIVACAINE HCI)	30 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	30	4
51662-1403-2	POLOCAINE(R) -MPF (MEPIVACAINE HCI)	30 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	30	4
51662-1403-2	POLOCAINE(R) -MPF (MEPIVACAINE HCI)	1 in 1 POUCH	INJECTION, SOLUTION	1	4
51662-1403-3	POLOCAINE(R) -MPF (MEPIVACAINE HCI)	25 in 1 CASE	INJECTION, SOLUTION	25	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1403	POLOCAINE(R) -MPF (MEPIVACAINE HCI) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	4	Current NDC, Legacy NDC, 4 package rows	20240131_996381e2-485b-9434-e053-2a95a90a08e1.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(R) -MPF (MEPIVACAINE HCI)	POLOCAINE(R) -MPF (MEPIVACAINE HCI)	HF Acquisition Co LLC, DBA HealthFirst	996381e2-485b-9434-e053-2a95a90a08e1	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089406 application number: ANDA089406 ndc (product): 51662-1403
Polocaine-MPF	MEPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	a27d0815-ae6b-4a21-a8f5-564c01e83814	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089406 application number: ANDA089406

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
1866503	mepivacaine HCl 1 % in 30 ML Injection	PSN	996381e2-485b-9434-e053-2a95a90a08e1	4
1866503	30 ML mepivacaine hydrochloride 10 MG/ML Injection	SCD	996381e2-485b-9434-e053-2a95a90a08e1	4
1866503	mepivacaine HCl 1 % per 30 ML Injection	SY	996381e2-485b-9434-e053-2a95a90a08e1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1403-1	51662140301	30 mL in 1 VIAL, SINGLE-DOSE (51662-1403-1)	30 ml	2019-12-10	0000-00-00	No	No	Current
51662-1403-2	51662140302	30 mL in 1 VIAL, SINGLE-DOSE	30 ml					Historical
51662-1403-3	51662140303	25 POUCH in 1 CASE (51662-1403-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1403-2) / 30 mL in 1 VIAL, SINGLE-DOSE	25 pouch	2023-01-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POLOCAINE(R) -MPF (MEPIVACAINE HCI)	HF Acquisition Co LLC, DBA HealthFirst	2024-01-29	HUMAN PRESCRIPTION DRUG LABEL	4