Application 211370

Type: ANDA
Sponsor: MICRO LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	SOLUTION;INTRAVENOUS	5MG/2ML (2.5MG/ML)	No	No
002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	SOLUTION;INTRAVENOUS	10MG/4ML (2.5MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211370-001	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2018-12-28
A211370-002	VERAPAMIL HYDROCHLORIDE	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP		2018-12-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211370-001	AP
A211370-002	AP

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 3 · 82 observed 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	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211370-001	VERAPAMIL HYDROCHLORIDE	5MG/2ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211370-002	VERAPAMIL HYDROCHLORIDE	10MG/4ML (2.5MG/ML)	SOLUTION / INTRAVENOUS	AP	2018-12-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211370-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211370-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211370-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211370-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211370-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211370-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211370-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211370-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211370-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211370-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211370-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211370-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211370-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211370-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211370-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211370-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211370-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211370-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211370-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211370-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211370-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211370-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211370-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211370-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211370-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211370-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211370-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211370-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211370-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211370-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211370-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211370-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211370-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211370-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211370-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211370-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211370-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211370-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211370-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211370-002	AP	1	`782e0a99824c…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9e04440f-4cee-990b-e053-2995a90a09e1	2023-05-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211370 application number: ANDA211370 ndc (product): 71872-7183
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	9f19a5b4-286c-2c3f-e053-2a95a90a51df	2023-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211370 application number: ANDA211370 ndc (product): 71872-7203
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Medical Purchasing Solutions, LLC	a2a4b816-417c-4a37-e053-2995a90a0220	2023-05-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211370 application number: ANDA211370 ndc (product): 71872-7210
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Armas Pharmaceuticals Inc.	2d595d9d-af88-474d-b622-d63d786f06a7	2020-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211370 application number: ANDA211370 ndc (product): 72485-109
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Armas Pharmaceuticals Inc.	51597adb-bfb1-4611-b577-8989724fc3a4	2020-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211370 application number: ANDA211370 ndc (product): 72485-108
Verapamil Hydrochloride	VERAPAMIL HYDROCHLORIDE	Micro Labs Limited	9c89764e-ff07-4077-a40f-91eb1c179af2	2019-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211370 application number: ANDA211370 ndc (product): 42571-313

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42571-313	Verapamil Hydrochloride	Verapamil Hydrochloride	Micro Labs Limited	ANDA	Current
42571-313	Verapamil Hydrochloride	Verapamil Hydrochloride	Micro Labs Limited	ANDA	Current
71872-7183	Verapamil Hydrochloride	Verapamil Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7203	Verapamil Hydrochloride	Verapamil Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7210	Verapamil Hydrochloride	Verapamil Hydrochloride	Medical Purchasing Solutions, LLC	ANDA	Current
72485-108	Verapamil Hydrochloride	Verapamil Hydrochloride	Armas Pharmaceuticals Inc.	ANDA	Current
72485-109	Verapamil Hydrochloride	Verapamil Hydrochloride	Armas Pharmaceuticals Inc.	ANDA	Current