Application 040851

Type: ANDA
Sponsor: MIKART

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 42.

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
A040851-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09
A040851-002	BENZONATATE	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09
A040851-003	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040851-002	BENZONATATE	150MG	CAPSULE / ORAL	2009-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040851-003	BENZONATATE	200MG	CAPSULE / ORAL	2009-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040851-001	BENZONATATE	100MG	CAPSULE / ORAL	2009-11-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A040851-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040851-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040851-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040851-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040851-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040851-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040851-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040851-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040851-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040851-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040851-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040851-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040851-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040851-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040851-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040851-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040851-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040851-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040851-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040851-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040851-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040851-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040851-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040851-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040851-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040851-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040851-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040851-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040851-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040851-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040851-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040851-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040851-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040851-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040851-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040851-003	AA	1	`ea99ee380514…`

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 6 · 112 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	PD-Rx Pharmaceuticals, Inc.	7a5460bf-5242-4726-9dfa-e215529842c3	2026-08-12	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	0151d970-fd80-482d-ad92-03015eef2618	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Redpharm Drug	5833ad0e-daae-1a93-e063-6394a90af88e	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	REMEDYREPACK INC.	07018b47-76f5-49d3-b7d3-081f82d382b2	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Epic Pharma LLC	9b35e9d5-7d72-4f51-a245-ad2467ab40e9	2026-08-03	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	REMEDYREPACK INC.	23a5de40-76d0-4117-8d31-2b2f8a6b0a28	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	REMEDYREPACK INC.	ed756746-4cbb-4196-a972-5a8c23702b2a	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Sportpharm LLC	df48d617-a3c2-4776-937d-ccfca651d4fc	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	St. Mary's Medical Park Pharmacy	3f686042-02bc-8a78-e063-6294a90a7f56	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	5728b147-33a0-4534-b936-3e02274d9467	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Major Pharmaceuticals	2256f7e4-b7e6-433f-941e-bf78ddcd55b2	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Golden State Medical Supply, Inc.	d580b1c9-d450-4032-acb2-0563c589ed2c	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	A-S Medication Solutions	e6f5f2c2-1c59-405c-97bf-ee73740869d2	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	A-S Medication Solutions	434130e1-c29c-4029-92c6-7d0f7a928e68	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Major Pharmaceuticals	324f65ae-09d1-4bd6-9d2b-593035201ecd	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	da093b5e-83a7-467e-9716-bc5827a18c20	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	865a6317-c697-4dbe-9074-4a955036cdd7	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bryant Ranch Prepack	0f91fd98-1a86-42aa-8055-d339bff73015	2026-06-26	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
Benzonatate	BENZONATATE	Bionpharma Inc.	2630be01-1d2d-4c40-8e56-8568ea89eacf	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Benzonatate generic name: BENZONATATE
BENZONATATE	BENZONATATE	Strides Pharma Science Limited	89f5d18e-5ef4-42a3-bc6f-abf4f308462b	2026-06-11	Warnings, Adverse reactions	Name fallback brand name: BENZONATATE generic name: BENZONATATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46672-280	benzonatate	benzonatate	Mikart, LLC	ANDA	Current
46672-280	benzonatate	benzonatate	Mikart, Inc.	ANDA	Current
46672-281	benzonatate	benzonatate	Mikart, LLC	ANDA	Current
46672-281	benzonatate	benzonatate	Mikart, Inc.	ANDA	Current
46672-282	benzonatate	benzonatate	Mikart, LLC	ANDA	Current
46672-282	benzonatate	benzonatate	Mikart, Inc.	ANDA	Current
69499-329	benzonatate	benzonatate	Solubiomix	ANDA	Current
69499-329	benzonatate	benzonatate	Solubiomix	ANDA	Current
69499-329	benzonatate	benzonatate	Solubiomix	ANDA	Current
69499-329	benzonatate	benzonatate	Solubiomix	ANDA	Current