Benzonatate

Product NDC: 68788-8336
11-digit product format: 687888336
Labeler code: 68788
Product ID: 68788-8336_cb8266bf-7543-4ac4-aaea-086a497079f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA211518
Marketing category: ANDA
Marketing start: 2023-04-06
Substance: BENZONATATE
Active strength: 200 mg/1
Pharmacologic classes: Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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	TE codes	Approval date
A211518-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22
A211518-002	BENZONATATE	BENZONATATE	150MG	CAPSULE / ORAL	AA	2019-02-22
A211518-003	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A211518-001	AA
A211518-002	AA
A211518-003	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 4 · 126 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
2026-08-18 06:07:40	2026-07	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL	AA	2019-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211518-002	BENZONATATE	150MG	CAPSULE / ORAL		2019-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211518-003	BENZONATATE	200MG	CAPSULE / ORAL	AA	2019-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211518-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2019-02-22	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211518-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211518-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211518-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211518-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211518-003	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211518-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211518-003	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211518-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211518-003	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211518-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211518-003	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211518-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211518-003	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211518-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211518-003	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211518-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211518-003	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211518-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211518-003	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211518-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211518-003	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211518-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211518-003	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211518-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211518-003	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211518-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211518-003	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211518-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211518-003	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211518-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211518-003	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211518-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211518-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211518-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211518-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211518-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211518-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211518-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211518-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211518-003	AA	1	`4b0b4de00fa7…`

Additional Listing Data#

Finished product: Yes
Brand name base: Benzonatate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZONATATE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5P4DHS6ENR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283417	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fe5e8a94-ac75-4657-a45a-1fe94dbe0d43	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc429dc2-e942-6686-8d72-b63c57e806aa	Product name	5	20190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9	Product name	3	20190215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-8336-1	Benzonatate	15 in 1 BOTTLE	CAPSULE	15	4
68788-8336-2	Benzonatate	20 in 1 BOTTLE	CAPSULE	20	4
68788-8336-3	Benzonatate	30 in 1 BOTTLE	CAPSULE	30	4
68788-8336-6	Benzonatate	60 in 1 BOTTLE	CAPSULE	60	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8336-1	EA - Each	68788-8336	07fc3e5a-6b8a-4cc7-94d9-19b03cbb2799	1	2023-04-07
68788-8336-2	EA - Each	68788-8336	95e541f3-d31a-4f8c-b87f-3a34d5758be6	1	2023-04-07
68788-8336-3	EA - Each	68788-8336	990ed44c-63e7-433a-8534-61ebbabf69c8	1	2023-04-07
68788-8336-6	EA - Each	68788-8336	422fb261-3701-46d0-9605-1ba61f08decb	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8336	BENZONATATE CAPSULE [PREFERRED PHARMACEUTICALS, INC.]	3	Current NDC, 4 package rows	20250209_fe5e8a94-ac75-4657-a45a-1fe94dbe0d43.zip

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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	Sportpharm LLC	df48d617-a3c2-4776-937d-ccfca651d4fc	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Bryant Ranch Prepack	da093b5e-83a7-467e-9716-bc5827a18c20	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Bryant Ranch Prepack	865a6317-c697-4dbe-9074-4a955036cdd7	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Bryant Ranch Prepack	0f91fd98-1a86-42aa-8055-d339bff73015	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Anvi Pharmaceuticals Inc	7c733168-355e-4753-8d52-59a06fb39952	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Redpharm drug, inc	f3c23663-0cb7-ffa4-e053-2a95a90a9ae0	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Camber Pharmaceuticals, Inc.	c21afd18-3b04-4f15-874b-25e0c768f801	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	XLCare Pharmaceuticals, Inc.	e33afd96-5ad3-4033-b067-981ac2ed2bea	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Preferred Pharmaceuticals, Inc.	fe5e8a94-ac75-4657-a45a-1fe94dbe0d43	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518 ndc (product): 68788-8336
Benzonatate	BENZONATATE	Bryant Ranch Prepack	da8fcba7-a43e-4463-96ac-104c7613d64f	2026-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Direct_rx	2b4b22e9-a03d-fb8f-e063-6394a90a8747	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	REMEDYREPACK INC.	9815f3f4-fb46-4796-a0ed-62a9e098286d	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	A-S Medication Solutions	3268cde5-65ae-43d2-95c6-b8bb4c32a6fd	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	NuCare Pharmaceuticals,Inc.	cfd54d90-c15d-0d02-e053-2995a90a8b28	2024-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Proficient Rx LP	47560d98-f4c4-4738-85fe-41cbed09ed59	2022-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Proficient Rx LP	8dcaeabf-e7da-4e0c-b6db-0bd425d6506e	2022-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Proficient Rx LP	45d9b32a-3198-49d5-addf-f077fec50b9c	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518
Benzonatate	BENZONATATE	Proficient Rx LP	f4337699-3279-4c08-94f4-caba6d866f63	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211518 application number: ANDA211518

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5P4DHS6ENR	BENZONATATE	104-31-4	BENZONATATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283417	benzonatate 200 MG Oral Capsule	PSN	fe5e8a94-ac75-4657-a45a-1fe94dbe0d43	4
283417	benzonatate 200 MG Oral Capsule	SCD	fe5e8a94-ac75-4657-a45a-1fe94dbe0d43	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-8336-1	68788833601	15 CAPSULE in 1 BOTTLE (68788-8336-1)	15 capsule	2023-04-06	No	No	Current
68788-8336-2	68788833602	20 CAPSULE in 1 BOTTLE (68788-8336-2)	20 capsule	2023-04-06	No	No	Current
68788-8336-3	68788833603	30 CAPSULE in 1 BOTTLE (68788-8336-3)	30 capsule	2023-04-06	No	No	Current
68788-8336-6	68788833606	60 CAPSULE in 1 BOTTLE (68788-8336-6)	60 capsule	2023-04-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BENZONATATE CAPSULES 100 mg Capsules 150 mg Capsules 200 mg Capsules (benzonatate, USP)	Preferred Pharmaceuticals, Inc.	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	4