BENZONATATE

Product NDC: 43063-980
11-digit product format: 430630980
Labeler code: 43063
Product ID: 43063-980_dc8f41a5-696b-5e65-e053-2a95a90a51fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BENZONATATE
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA040682
Marketing category: ANDA
Marketing start: 2018-05-01
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43063-980		D	Discontinued by firm	2026-08-03
excluded package	package	43063-980	43063-980-01	D	Discontinued by firm	2026-08-03
excluded package	package	43063-980	43063-980-30	D	Discontinued by firm	2026-08-03
excluded package	package	43063-980	43063-980-82	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	43063-980-01
excluded package	package	43063-980-82
excluded package	package	43063-980-30

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
A040682-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-07-30
A040682-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040682-001	AA
A040682-002	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	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040682-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	2007-07-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040682-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-07-30	`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	A040682-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040682-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040682-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040682-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040682-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040682-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040682-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040682-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040682-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040682-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040682-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040682-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040682-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040682-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040682-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040682-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040682-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040682-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040682-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040682-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040682-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040682-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040682-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040682-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040682-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040682-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040682-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040682-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040682-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040682-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040682-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040682-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040682-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040682-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040682-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040682-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040682-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040682-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040682-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040682-002	AA	1	`782e0a99824c…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-980-01	EA - Each	43063-980	06e2d1c9-4571-4a05-8469-19e61470fccd	1	2019-06-19
43063-980-30	EA - Each	43063-980	d8232b0e-914d-41fb-a0d6-43ea0224e5e1	1	2020-08-06
43063-980-82	EA - Each	43063-980	f5d94b18-6049-4573-bbfa-b33f951bb4ab	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-980	BENZONATATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	14	Legacy NDC	20241019_5537a8c2-4493-43e3-89f8-91da473cae3d.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	Redpharm Drug	4972e1e4-7eac-a770-e063-6294a90abe28	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682
Benzonatate	BENZONATATE	Redpharm Drug	46e97547-23d9-114a-e063-6394a90a920b	2025-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682
Benzonatate	BENZONATATE	Amneal Pharmaceuticals LLC	199a42ae-4d19-4e68-934d-dabd27084988	2024-10-23	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682
Benzonatate	BENZONATATE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	f32014c7-bc0c-4edb-b591-7baa6664d74b	2024-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682
Benzonatate	BENZONATATE	Chartwell RX, LLC	8a17033c-1ad3-4c7a-92ee-f55756833986	2023-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682
BENZONATATE	BENZONATATE	Bryant Ranch Prepack	418c4c4e-6195-4d0d-a559-ee3f10147b5b	2023-03-24	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682
Benzonatate	BENZONATATE	Proficient Rx LP	19f1e761-69e9-4330-ad3c-1f1180d70cb0	2021-01-01	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 040682 application number: ANDA040682

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-980-01	43063098001	100 CAPSULE in 1 BOTTLE, PLASTIC (43063-980-01)	100 capsule	2019-05-06	0000-00-00	No	No	Current
43063-980-30	43063098030	30 CAPSULE in 1 BOTTLE, PLASTIC (43063-980-30)	30 capsule	2020-07-13	0000-00-00	No	No	Current
43063-980-82	43063098082	500 CAPSULE in 1 BOTTLE, PLASTIC (43063-980-82)	500 capsule	2019-12-13	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 Rx Only	PD-Rx Pharmaceuticals, Inc.	2024-10-17	HUMAN PRESCRIPTION DRUG LABEL	14