Application 206948

Type: ANDA
Sponsor: PURACAP PHARM LLC

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 43.

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
A206948-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19
A206948-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206948-001	AA
A206948-002	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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	RS	2018-12-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	RS	2018-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2018-12-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2018-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2018-12-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2018-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2018-12-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2018-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2018-12-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2018-12-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206948-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206948-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206948-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206948-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206948-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206948-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206948-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206948-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206948-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206948-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206948-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206948-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206948-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206948-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206948-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206948-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206948-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206948-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206948-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206948-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206948-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206948-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206948-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206948-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206948-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206948-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206948-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206948-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206948-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206948-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206948-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206948-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206948-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206948-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206948-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206948-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206948-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206948-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206948-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206948-002	AA	1	`74a2ff9319b5…`

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 2 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	NuCare Pharmaceuticals,Inc.	a2167f23-95bf-baa2-e053-2a95a90a7bbd	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948 ndc (product): 68071-5223
Benzonatate	BENZONATATE	Proficient Rx LP	a8f5bdb6-677b-416c-834e-60307b566bd7	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948 ndc (product): 71205-643
Benzonatate	BENZONATATE	Proficient Rx LP	46b4f05c-9261-42fc-a016-c99eebab5646	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948 ndc (product): 71205-632

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 · 62 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7153	Benzonatate	Benzonatate	Major Pharmaceuticals	ANDA	Current
42806-714	Benzonatate	Benzonatate	Epic Pharma LLC	ANDA	Current
42806-715	Benzonatate	Benzonatate	Epic Pharma LLC	ANDA	Current
50090-5409	Benzonatate	Benzonatate	A-S Medication Solutions	ANDA	Current
50090-5986	Benzonatate	Benzonatate	A-S Medication Solutions	ANDA	Current
50090-6294	Benzonatate	Benzonatate	A-S Medication Solutions	ANDA	Current
53002-0413	Benzonatate	Benzonatate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-5892	Benzonatate	Benzonatate	RPK Pharmaceuticals, Inc.	ANDA	Current
60760-700	Benzonatate	Benzonatate	St. Mary's Medical Park Pharmacy	ANDA	Current
67296-1751	Benzonatate	Benzonatate	RedPharm Drug, Inc.	ANDA	Current
67296-1751	Benzonatate	Benzonatate	RedPharm Drug, Inc.	ANDA	Current
67296-1782	Benzonatate	Benzonatate	RedPharm Drug, Inc.	ANDA	Current
67296-1782	Benzonatate	Benzonatate	RedPharm Drug, Inc.	ANDA	Current
68071-1395	Benzonatate	Benzonatate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1395	Benzonatate	Benzonatate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5083	Benzonatate	Benzonatate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5083	Benzonatate	Benzonatate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5083	Benzonatate	Benzonatate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5223	Benzonatate	Benzonatate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5223	Benzonatate	Benzonatate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7560	Benzonatate	Benzonatate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7560	Benzonatate	Benzonatate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7560	Benzonatate	Benzonatate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7607	Benzonatate	Benzonatate	Preferred Pharmaceuticals Inc	ANDA	Current
68788-7607	Benzonatate	Benzonatate	Preferred Pharmaceuticals Inc	ANDA	Current
68788-7607	Benzonatate	Benzonatate	Preferred Pharmaceuticals Inc	ANDA	Current
70518-2491	Benzonatate	Benzonatate	REMEDYREPACK INC.	ANDA	Current
70518-2491	Benzonatate	Benzonatate	REMEDYREPACK INC.	ANDA	Current
70518-2491	Benzonatate	Benzonatate	REMEDYREPACK INC.	ANDA	Current
70518-2491	Benzonatate	Benzonatate	REMEDYREPACK INC.	ANDA	Current
70518-2491	Benzonatate	Benzonatate	REMEDYREPACK INC.	ANDA	Current
70518-2873	Benzonatate	Benzonatate	REMEDYREPACK INC.	ANDA	Current
70518-2873	Benzonatate	Benzonatate	REMEDYREPACK INC.	ANDA	Current
70518-2873	Benzonatate	Benzonatate	REMEDYREPACK INC.	ANDA	Current
70518-2873	Benzonatate	Benzonatate	REMEDYREPACK INC.	ANDA	Current
70934-675	Benzonatate	Benzonatate	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-675	Benzonatate	Benzonatate	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current
70934-884	Benzonatate	Benzonatate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-893	Benzonatate	Benzonatate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-893	Benzonatate	Benzonatate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-893	Benzonatate	Benzonatate	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-632	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71205-632	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71205-643	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71205-643	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71205-643	Benzonatate	Benzonatate	Proficient Rx LP	ANDA	Current
71335-1544	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current
71335-1553	Benzonatate	Benzonatate	Bryant Ranch Prepack	ANDA	Current
72189-192	BENZONATATE	BENZONATATE	DIRECT RX	ANDA	Current
72189-192	BENZONATATE	BENZONATATE	DIRECT RX	ANDA	Current
72189-192	BENZONATATE	BENZONATATE	DIRECT RX	ANDA	Current
72189-194	BENZONATATE	BENZONATATE	DIRECT RX	ANDA	Current
72189-194	BENZONATATE	BENZONATATE	DIRECT RX	ANDA	Current
72189-194	BENZONATATE	BENZONATATE	DIRECT RX	ANDA	Current
72189-194	BENZONATATE	BENZONATATE	DIRECT RX	ANDA	Current
72789-230	Benzonatate	Benzonatate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-230	Benzonatate	Benzonatate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-230	Benzonatate	Benzonatate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-230	Benzonatate	Benzonatate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-231	Benzonatate	Benzonatate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-232	Benzonatate	Benzonatate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-232	Benzonatate	Benzonatate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current