Benzonatate

Product NDC: 63629-2474
11-digit product format: 636292474
Labeler code: 63629
Product ID: 63629-2474_392098b9-912f-42b7-90fe-0b81f16d089a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202765
Marketing category: ANDA
Marketing start: 2017-09-07
Substance: BENZONATATE
Active strength: 100 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
A202765-001	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA		2015-07-31
A202765-002	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA		2017-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202765-001	AA
A202765-002	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	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202765-001	BENZONATATE	200MG	CAPSULE / ORAL	AA	2015-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202765-002	BENZONATATE	100MG	CAPSULE / ORAL	AA	2017-08-25	`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	A202765-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202765-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202765-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202765-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202765-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202765-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202765-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202765-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202765-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202765-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202765-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202765-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202765-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202765-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202765-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202765-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202765-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202765-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202765-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202765-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202765-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202765-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202765-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202765-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202765-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202765-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202765-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202765-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202765-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202765-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202765-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202765-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202765-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202765-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202765-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202765-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202765-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202765-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202765-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202765-002	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	100 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
197397	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
77b51a56-43e8-4be0-b993-28b1cecdbf14	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	Strength	SPL version
63629-2474-1	Benzonatate	100 in 1 BOTTLE	CAPSULE	100		107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2474-1	EA - Each	63629-2474	38cb42be-d25f-416a-957b-9c27540d4295	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-2474	BENZONATATE CAPSULE [BRYANT RANCH PREPACK]	107	Current NDC, Legacy NDC, 1 package rows	20240806_77b51a56-43e8-4be0-b993-28b1cecdbf14.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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	St. Mary's Medical Park Pharmacy	3f686042-02bc-8a78-e063-6294a90a7f56	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Bryant Ranch Prepack	e1bf84c8-fc88-4f43-8655-7ce95a4da51f	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	REMEDYREPACK INC.	07018b47-76f5-49d3-b7d3-081f82d382b2	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Redpharm Drug	44f2826e-20ff-b53c-e063-6394a90a9630	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Bryant Ranch Prepack	a8d13a2b-b7cf-4c33-ad2f-fda5c7e598b9	2025-10-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	REMEDYREPACK INC.	284a8cbb-632b-41ba-97b8-07fe70c14a83	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Bryant Ranch Prepack	a52856fc-049d-48cf-8cc4-de059850e31a	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Bryant Ranch Prepack	5008eb9e-b209-4393-8d13-bb92976e8dde	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Rising Pharma Holdings, Inc.	0ca22f92-9750-4eb4-8cdb-ebd3b12691cc	2024-06-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Bryant Ranch Prepack	5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Bryant Ranch Prepack	77b51a56-43e8-4be0-b993-28b1cecdbf14	2024-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765 ndc (product): 63629-2474
Benzonatate	BENZONATATE	A-S Medication Solutions	cf41278a-3fb6-4bcb-b86e-016a41314625	2024-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Bryant Ranch Prepack	9083ff4d-dd50-4931-b14f-cfa08fccba8b	2024-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Bryant Ranch Prepack	2471d5d9-ea9e-482a-811d-ad173b253be7	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Precision Dose, Inc.	978d0c83-bc01-49b2-a08a-61d72ee58ff8	2023-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Bryant Ranch Prepack	6c5f67b0-3788-44e7-8dce-bcd58883d4a0	2023-11-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	A-S Medication Solutions	36c3f916-cc4e-4e09-8419-4d6b64157e32	2023-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Bryant Ranch Prepack	ae3099cd-a88e-4273-bf7f-b68419d03b3e	2023-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Bryant Ranch Prepack	281b849d-c380-474c-94b1-1f3778504943	2023-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765
Benzonatate	BENZONATATE	Bryant Ranch Prepack	1d5450e9-85bb-471e-b6f3-c2ec7a34f128	2023-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202765 application number: ANDA202765

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
197397	benzonatate 100 MG Oral Capsule	PSN	77b51a56-43e8-4be0-b993-28b1cecdbf14	107
197397	benzonatate 100 MG Oral Capsule	SCD	77b51a56-43e8-4be0-b993-28b1cecdbf14	107

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2474-1	63629247401	100 CAPSULE in 1 BOTTLE (63629-2474-1)	100 capsule	2017-09-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benzonatate Capsules USP, 100 mg and 200 mg	Bryant Ranch Prepack	2024-03-15	HUMAN PRESCRIPTION DRUG LABEL	107