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 3 of 6 · 106 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	Northwind Health Company, LLC	da6bcd14-2294-e7df-e053-2995a90a4526	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Northwind Health Company, LLC	da6cead3-2859-df03-e053-2a95a90a010b	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
BENZONATATE	BENZONATATE	Northwind Health Company, LLC	da807eb3-349e-61b9-e053-2995a90a0e21	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: BENZONATATE generic name: BENZONATATE
Benzonatate	BENZONATATE	Redpharm Drug	46e97547-23d9-114a-e063-6394a90a920b	2025-12-27	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
BENZONATATE	BENZONATATE	QPharma, Inc.	55c4ae18-3e37-4caf-9fdb-9d307970b5f9	2025-12-21	Warnings, Adverse reactions	Name fallback brand name: BENZONATATE generic name: BENZONATATE
Benzonatate	BENZONATATE	Redpharm Drug	32524a8a-4cee-26c0-e063-6294a90aa898	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
BENZONATATE	BENZONATATE	Coupler LLC	463d5cff-3cd6-58fc-e063-6394a90a996b	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: BENZONATATE generic name: BENZONATATE
Benzonatate	BENZONATATE	QPharma Inc	fbd07fb0-c49c-a838-e053-6394a90a5f0e	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Redpharm Drug	44f2826e-20ff-b53c-e063-6394a90a9630	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
BENZONATATE	BENZONATATE	Ascend Laboratories, LLC	54374c04-63b9-49fa-b6a2-4a711e322d8e	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: BENZONATATE generic name: BENZONATATE
Benzonatate	BENZONATATE	A-S Medication Solutions	1b5364d2-bbd5-4c05-a7b5-a5cdbf1d37e9	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	a8d13a2b-b7cf-4c33-ad2f-fda5c7e598b9	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	751d9d60-cd6b-4aa1-b68f-61b86c4059ad	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	a52856fc-049d-48cf-8cc4-de059850e31a	2025-06-26	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	995ebc53-4e13-4c1d-b301-71ac83c6def8	2025-06-04	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Asclemed USA, Inc.	25ed5206-b322-486f-9e54-14125f6e74c5	2025-04-18	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	RedPharm Drug, Inc.	a2f6acff-70ff-79f1-e053-2a95a90a6005	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	RedPharm Drug, Inc.	f3c2acfc-f598-50ab-e053-2a95a90a11e7	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
BENZONATATE	BENZONATATE	DIRECT RX	673bf826-a005-7a38-e053-2991aa0a4cb5	2025-02-17	Warnings, Adverse reactions	Name fallback brand name: BENZONATATE generic name: BENZONATATE
Benzonatate	BENZONATATE	Coupler LLC	2ce035ff-42cb-d8ef-e063-6294a90a0c06	2025-01-29	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