Application 081297

Type: ANDA
Sponsor: BIONPHARMA INC

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	200MG	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
A081297-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA		1993-01-29
A081297-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A081297-001	AA
A081297-002	AA

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	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`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	A081297-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A081297-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081297-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081297-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081297-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A081297-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081297-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081297-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081297-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081297-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081297-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081297-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081297-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081297-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081297-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081297-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081297-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081297-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081297-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A081297-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081297-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081297-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081297-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081297-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081297-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081297-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081297-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A081297-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081297-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081297-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081297-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A081297-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081297-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A081297-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081297-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A081297-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081297-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A081297-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081297-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A081297-002	AA	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	Bryant Ranch Prepack	5728b147-33a0-4534-b936-3e02274d9467	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297 ndc (product): 71335-1880
Benzonatate	BENZONATATE	Golden State Medical Supply, Inc.	d580b1c9-d450-4032-acb2-0563c589ed2c	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297 ndc (product): 60429-927 ndc (product): 60429-914
Benzonatate	BENZONATATE	Bionpharma Inc.	2630be01-1d2d-4c40-8e56-8568ea89eacf	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297 ndc (product): 69452-143 ndc (product): 69452-144
Benzonatate	BENZONATATE	Bryant Ranch Prepack	540d2bc6-11dc-43d7-b616-b89d75b81cd1	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297 ndc (product): 71335-1927
Benzonatate	BENZONATATE	Coupler LLC	2ce035ff-42cb-d8ef-e063-6294a90a0c06	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297
Benzonatate	BENZONATATE	NuCare Pharmaceuticals,Inc.	9cab4544-e0ab-3fdd-e053-2995a90ad049	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297 ndc (product): 68071-5156
Benzonatate	BENZONATATE	NuCare Pharmaceuticals,Inc.	96b260c3-e177-73c3-e053-2a95a90a775e	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297 ndc (product): 68071-5105
Benzonatate	BENZONATATE	Aphena Pharma Solutions - Tennessee, LLC	3bd33aec-9a30-4581-bd28-6cfb67772cef	2023-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297
Benzonatate	BENZONATATE	Proficient Rx LP	bc435603-ddc4-4083-af09-2e562defbe7f	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297 ndc (product): 71205-605
Benzonatate	BENZONATATE	Proficient Rx LP	0d14cbf4-f43f-4ad2-8e8b-7a844e417702	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297 ndc (product): 71205-067

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-1349	Benzonatate	Benzonatate	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
53002-0411	Benzonatate	Benzonatate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-0411	Benzonatate	Benzonatate	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-363	Benzonatate	Benzonatate	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60429-905	Benzonatate	Benzonatate	Golden State Medical Supply, Inc.	ANDA	Current
60429-905	Benzonatate	Benzonatate	Golden State Medical Supply, Inc.	ANDA	Current
60429-914	Benzonatate	Benzonatate	Golden State Medical Supply, Inc.	ANDA	Current
60429-914	Benzonatate	Benzonatate	Golden State Medical Supply, Inc.	ANDA	Current
60429-914	Benzonatate	Benzonatate	Golden State Medical Supply, Inc.	ANDA	Current
60429-927	Benzonatate	Benzonatate	Golden State Medical Supply, Inc.	ANDA	Current
60429-927	Benzonatate	Benzonatate	Golden State Medical Supply, Inc.	ANDA	Current
60429-927	Benzonatate	Benzonatate	Golden State Medical Supply, Inc.	ANDA	Current
63629-2443	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current
63629-2443	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current
63629-2444	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current
63629-2444	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current
63629-2655	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current
66116-513	Benzonatate	Benzonatate	MedVantx, Inc.	ANDA	Current
67296-1361	Benzonatate	Benzonatate	RedPharm Drug, Inc.	ANDA	Current
67296-1361	Benzonatate	Benzonatate	RedPharm Drug, Inc.	ANDA	Current
67296-1371	Benzonatate	Benzonatate	RedPharm Drug, Inc.	ANDA	Current
67296-1371	Benzonatate	Benzonatate	RedPharm Drug, Inc.	ANDA	Current
67296-1576	Benzonatate	Benzonatate	RedPharm Drug, Inc.	ANDA	Current
67296-1576	Benzonatate	Benzonatate	RedPharm Drug, Inc.	ANDA	Current
67296-1576	Benzonatate	Benzonatate	RedPharm Drug, Inc.	ANDA	Current
68071-5105	Benzonatate	Benzonatate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5105	Benzonatate	Benzonatate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5156	Benzonatate	Benzonatate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5156	Benzonatate	Benzonatate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7569	Benzonatate	Benzonatate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7569	Benzonatate	Benzonatate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8133	Benzonatate	Benzonatate	Preferred Pharmaceuticals Inc..	ANDA	Current
69387-119	Benzonatate	Benzonatate	Banner Life Sciences LLC.	ANDA	Current
69387-120	Benzonatate	Benzonatate	Banner Life Sciences LLC.	ANDA	Current
69452-143	Benzonatate	Benzonatate	Bionpharma Inc.	ANDA	Current
69452-144	Benzonatate	Benzonatate	Bionpharma Inc.	ANDA	Current
70934-943	Benzonatate	Benzonatate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-943	Benzonatate	Benzonatate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-067	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71205-067	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71205-067	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71205-605	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71205-605	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71335-0054	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current
71335-1880	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current
71335-1927	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current