Benzonatate

Product NDC: 68071-1395
Requested package NDC: 68071-1395-5
11-digit product format: 680711395
Labeler code: 68071
Product ID: 68071-1395_1d79b80a-e648-7d7d-e063-6294a90a82bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA206948
Marketing category: ANDA
Marketing start: 2018-12-21
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: 2026-12-31
Current FDA listing: Yes

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
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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2018-12-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2018-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206948-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2018-12-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206948-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2018-12-19	`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	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…`
2022-03-09 01:35 UTC	2022-03	A206948-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206948-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206948-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206948-002	AA	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Benzonatate
Listing expiration: 2026-12-31

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
941afb1f-348b-4340-e053-2995a90ac370	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-12-06	Benzonatate Capsules, USP
2023-01-30	Benzonatate Capsules, USP
2021-02-10	Benzonatate Capsules, USP
2021-01-29	Benzonatate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-1395-3	Benzonatate	30 in 1 BOTTLE	CAPSULE	30		4
68071-1395-5	Benzonatate	45 in 1 BOTTLE	CAPSULE	45		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-1395	BENZONATATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 2 package rows	20240719_941afb1f-348b-4340-e053-2995a90ac370.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	REMEDYREPACK INC.	23a5de40-76d0-4117-8d31-2b2f8a6b0a28	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	REMEDYREPACK INC.	ed756746-4cbb-4196-a972-5a8c23702b2a	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	A-S Medication Solutions	e6f5f2c2-1c59-405c-97bf-ee73740869d2	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	A-S Medication Solutions	434130e1-c29c-4029-92c6-7d0f7a928e68	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	Major Pharmaceuticals	324f65ae-09d1-4bd6-9d2b-593035201ecd	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	St. Mary's Medical Park Pharmacy	96250e05-4608-7d5c-e053-2995a90ad57a	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	Cardinal Health 107, LLC	b46f231a-65d3-400d-ae6b-3216830807a2	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	Sportpharm LLC	0e8f2562-2449-430f-85bb-f9195644cdfa	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	Preferred Pharmaceuticals Inc	3309040d-e240-42f6-9c51-5c54604a3896	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	Preferred Pharmaceuticals Inc.	f2cd05a6-2b8b-4731-b97b-b6677fbabbcf	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	A-S Medication Solutions	14550e43-1d1f-4dc1-a3f2-aac0d78a7118	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	Northwind Health Company, LLC	da6bcd14-2294-e7df-e053-2995a90a4526	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	Northwind Health Company, LLC	da6cead3-2859-df03-e053-2a95a90a010b	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	QPharma Inc	fbd07fb0-c49c-a838-e053-6394a90a5f0e	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	Asclemed USA, Inc.	25ed5206-b322-486f-9e54-14125f6e74c5	2025-04-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	RedPharm Drug, Inc.	a2f6acff-70ff-79f1-e053-2a95a90a6005	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	PD-Rx Pharmaceuticals, Inc.	70e157f2-1670-422c-a70d-f9576e1647ea	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	PD-Rx Pharmaceuticals, Inc.	55b64aee-d4c4-4aad-9016-0dd879e979e6	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
Benzonatate	BENZONATATE	PD-Rx Pharmaceuticals, Inc.	7a5460bf-5242-4726-9dfa-e215529842c3	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948
BENZONATATE	BENZONATATE	DIRECT RX	bec39717-eb88-6ca1-e053-2a95a90a9d9d	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206948 application number: ANDA206948

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	941afb1f-348b-4340-e053-2995a90ac370	4
283417	benzonatate 200 MG Oral Capsule	SCD	941afb1f-348b-4340-e053-2995a90ac370	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-1395-5	68071139505	45 CAPSULE in 1 BOTTLE (68071-1395-5)	45 capsule	2019-10-04	No	No	Current