Application 212482

Type: ANDA
Sponsor: ACRUX DDS PTY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	CREAM;TOPICAL	2.5%;2.5%	No	No

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
A212482-001	LIDOCAINE AND PRILOCAINE	LIDOCAINE; PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB		2021-07-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A212482-001	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL		2021-07-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212482-001	LIDOCAINE AND PRILOCAINE	2.5%;2.5%	CREAM / TOPICAL	AB	2021-07-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212482-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212482-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212482-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212482-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212482-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212482-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212482-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212482-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212482-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212482-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212482-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212482-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212482-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212482-001	AB	1	`8072bd15b7f6…`
2021-12-28 21:50 UTC	2021-12	A212482-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212482-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212482-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212482-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212482-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212482-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212482-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212482-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212482-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212482-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212482-001	AB	1	`a50c72e98297…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Padagis US LLC	6e1635f7-dcae-441b-bbf7-495661fb66ae	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482 ndc (product): 0574-2042
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Preferred Pharmaceuticals Inc.	82111bef-460f-4948-a19c-1d2063427ee4	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Bryant Ranch Prepack	3cd9a055-8b9b-4dff-967b-54023df72e43	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Bryant Ranch Prepack	889a8ba8-4058-49e1-8b28-08a3afbf280f	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Bryant Ranch Prepack	5bee9fab-a493-448e-b68c-fb58156d49b6	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	NuCare Pharmaceuticals, Inc.	365e59a2-b970-2ab1-e063-6294a90acfa9	2025-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	Bryant Ranch Prepack	2cd9f2a5-3726-4c74-b561-1555faf8ea88	2024-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482 ndc (product): 63629-9604
LIDOCAINE AND PRILOCAINE	LIDOCAINE AND PRILOCAINE	A-S Medication Solutions	a4c310f5-e83e-4e40-a73d-818da5f49fec	2023-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212482 application number: ANDA212482

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0574-2042	LIDOCAINE AND PRILOCAINE	Lidocaine and Prilocaine	Padagis US LLC	ANDA	Current
63629-9604	LIDOCAINE AND PRILOCAINE	Lidocaine and Prilocaine	Bryant Ranch Prepack	ANDA	Current