POLOCAINE (MEPIVACAINE HCl)

Product NDC: 51662-1535
11-digit product format: 516621535
Labeler code: 51662
Product ID: 51662-1535_1034d0b4-c691-2b1c-e063-6394a90a6d8e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: POLOCAINE (MEPIVACAINE HCl)
Dosage form: INJECTION, SOLUTION
Route: INFILTRATION
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: ANDA089410
Marketing category: ANDA
Marketing start: 2021-05-10
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 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
2026-08-18 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…`
2022-09-29 23:25 UTC	2022-09	A089410-001	POLOCAINE	2%	INJECTABLE / INJECTION	AP		1986-12-01	`e64feba35796…`

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	A089410-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089410-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089410-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089410-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089410-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089410-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089410-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089410-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089410-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089410-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089410-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089410-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089410-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089410-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089410-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089410-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089410-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089410-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089410-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089410-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089410-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089410-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089410-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089410-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089410-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089410-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089410-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089410-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089410-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089410-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089410-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089410-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089410-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089410-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089410-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089410-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089410-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: POLOCAINE (MEPIVACAINE HCl)
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MEPIVACAINE HYDROCHLORIDE	20 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
1012737	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
c20406a6-5611-59e4-e053-2995a90a3c8f	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51662-1535-2	POLOCAINE (MEPIVACAINE HCl)	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50	3
51662-1535-2	POLOCAINE (MEPIVACAINE HCl)	1 in 1 POUCH	INJECTION, SOLUTION	1	3
51662-1535-3	POLOCAINE (MEPIVACAINE HCl)	21 in 1 BOX	INJECTION, SOLUTION	21	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1535	POLOCAINE (MEPIVACAINE HCL) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	3	Current NDC, Legacy NDC, 3 package rows	20240201_c20406a6-5611-59e4-e053-2995a90a3c8f.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	c20406a6-5611-59e4-e053-2995a90a3c8f	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089410 application number: ANDA089410 ndc (product): 51662-1535
Polocaine-MPF	MEPIVACAINE HYDROCHLORIDE	Fresenius Kabi USA, LLC	a27d0815-ae6b-4a21-a8f5-564c01e83814	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089410 application number: ANDA089410

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
1012737	mepivacaine HCl 2 % Injectable Solution	PSN	c20406a6-5611-59e4-e053-2995a90a3c8f	3
1012737	mepivacaine hydrochloride 20 MG/ML Injectable Solution	SCD	c20406a6-5611-59e4-e053-2995a90a3c8f	3
1012737	mepivacaine HCl 2 % Injectable Solution	SY	c20406a6-5611-59e4-e053-2995a90a3c8f	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1535-2	51662153502	50 mL in 1 VIAL, MULTI-DOSE	50 ml					Historical
51662-1535-3	51662153503	21 POUCH in 1 BOX (51662-1535-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1535-2) / 50 mL in 1 VIAL, MULTI-DOSE	21 pouch	2021-05-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POLOCAINE (MEPIVACAINE HCl INJECTION, USP) 2% 1000mg/50mL (20mg/mL)	HF Acquisition Co LLC, DBA HealthFirst	2024-01-30	HUMAN PRESCRIPTION DRUG LABEL	3