Application 210562

Type: ANDA
Sponsor: QINGDAO BAHEAL PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENZONATATE	BENZONATATE	CAPSULE;ORAL	100MG	No	No
002	BENZONATATE	BENZONATATE	CAPSULE;ORAL	150MG	No	No
003	BENZONATATE	BENZONATATE	CAPSULE;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A210562-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09
A210562-002	BENZONATATE	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09
A210562-003	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210562-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210562-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210562-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210562-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210562-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210562-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210562-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210562-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210562-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210562-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210562-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210562-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210562-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210562-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210562-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210562-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210562-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210562-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210562-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210562-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210562-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210562-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210562-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210562-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210562-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210562-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210562-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210562-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210562-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210562-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210562-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210562-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210562-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210562-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210562-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210562-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210562-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210562-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210562-003	AA	1	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210562-001	AA	1	`9b2671bbb829…`

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 4 of 6 · 106 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BENZONATATE	BENZONATATE	DIRECT RX	bec39717-eb88-6ca1-e053-2a95a90a9d9d	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: BENZONATATE generic name: BENZONATATE
Benzonatate	BENZONATATE	Zydus Lifesciences Limited	abb4360a-4c52-45b6-9b80-df3c1bfc4c59	2024-11-25		Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Amneal Pharmaceuticals LLC	199a42ae-4d19-4e68-934d-dabd27084988	2024-10-23	Boxed warning, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	A-S Medication Solutions	3268cde5-65ae-43d2-95c6-b8bb4c32a6fd	2024-10-21	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	American Health Packaging	9a71725a-64b6-4800-a79c-aa4b2d74d44f	2024-09-30	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	NuCare Pharmaceuticals,Inc.	cfd54d90-c15d-0d02-e053-2995a90a8b28	2024-09-30	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	f32014c7-bc0c-4edb-b591-7baa6664d74b	2024-09-29	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	5008eb9e-b209-4393-8d13-bb92976e8dde	2024-08-20	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	NCS HealthCare of KY, LLC dba Vangard Labs	6f5c19ad-d811-4196-a9c3-4f6b89626b83	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	93f4935b-ba15-4a99-bfa9-96ca99a1ddc1	2024-08-07	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	NuCare Pharmaceuticals,Inc.	941afb1f-348b-4340-e053-2995a90ac370	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	NuCare Pharmaceuticals,Inc.	9cab4544-e0ab-3fdd-e053-2995a90ad049	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	NuCare Pharmaceuticals,Inc.	a2167f23-95bf-baa2-e053-2a95a90a7bbd	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	NuCare Pharmaceuticals,Inc.	96b260c3-e177-73c3-e053-2a95a90a775e	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Rising Pharma Holdings, Inc.	0ca22f92-9750-4eb4-8cdb-ebd3b12691cc	2024-06-07	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f	2024-05-23	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	77b51a56-43e8-4be0-b993-28b1cecdbf14	2024-03-15	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	A-S Medication Solutions	cf41278a-3fb6-4bcb-b86e-016a41314625	2024-01-29	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	9083ff4d-dd50-4931-b14f-cfa08fccba8b	2024-01-12	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	2471d5d9-ea9e-482a-811d-ad173b253be7	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
11788-027	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-027	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-027	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-027	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-027	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-027	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-028	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-028	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-028	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-028	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-028	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-028	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-029	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-029	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-029	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-029	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-029	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current
11788-029	benzonatate	benzonatate	AiPing Pharmaceutical, Inc.	ANDA	Current