benzonatate

Product NDC: 11788-027
Requested package NDC: 11788-027-01
11-digit product format: 117880027
Labeler code: 11788
Product ID: 11788-027_eba5c6f6-e360-8022-e053-2995a90a2409
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: AiPing Pharmaceutical, Inc.
Application: ANDA210562
Marketing category: ANDA
Marketing start: 2019-03-14
Marketing end: 0000-00-00
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	11788-027	11788-027-01	I	Inactivated by FDA		2026-08-17

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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	Approval date
A210562-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09
A210562-002	BENZONATATE	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09
A210562-003	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210562-002	BENZONATATE	150MG	CAPSULE / ORAL	2018-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210562-003	BENZONATATE	200MG	CAPSULE / ORAL	2018-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210562-001	BENZONATATE	100MG	CAPSULE / ORAL	2018-11-09	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210562-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210562-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210562-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210562-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210562-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210562-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210562-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210562-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210562-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210562-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210562-002	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210562-003	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210562-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210562-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210562-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210562-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210562-002	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210562-003	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210562-001	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210562-002	AA	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210562-003	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210562-001	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210562-002	AA	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210562-003	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210562-001	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210562-002	AA	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210562-003	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210562-001	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210562-002	AA	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210562-003	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210562-001	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210562-002	AA	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210562-003	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210562-001	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210562-002	AA	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A210562-003	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210562-001	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210562-002	AA	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A210562-003	AA	1	`ea99ee380514…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210562-001	AA	1	`9b2671bbb829…`

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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11788-027-00	2024-01-30	C162847	48780-1	1030e365-2fc0-111a-e063-dadaa90a10e2	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
11788-027-01	2024-01-30	C162847	48780-1	1030e365-6573-111a-e063-dadaa90a10e2	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
11788-027-05	2024-01-30	C162847	48780-1	1030e365-6573-111a-e063-dadaa90a10e2	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11788-027-00	benzonatate	24000 in 1 CARTON	CAPSULE	24000	3
11788-027-01	benzonatate	100 in 1 BOTTLE	CAPSULE	100	3
11788-027-05	benzonatate	500 in 1 BOTTLE	CAPSULE	500	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11788-027-01	EA - Each	11788-027	6069eafb-b1c5-40fd-899e-0bf4e0a4a7f4	1	2020-01-03
11788-027-05	EA - Each	11788-027	69f23cac-d7c9-4242-af5b-12fc50f156f2	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11788-027	BENZONATATE CAPSULE [AIPING PHARMACEUTICAL, INC.]	3	Legacy NDC, 2 package rows	20221023_b0da7a68-29ff-48aa-a52d-e5b393f6b4f6.zip
11788-027	BENZONATATE CAPSULE [AIPING PHARMACEUTICAL, INC.]	3	Legacy NDC, 1 package rows	20200701_7c210c0e-72b8-9656-e053-2991aa0a9455.zip

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	7c210c0e-72b8-9656-e053-2991aa0a9455	3
197397	benzonatate 100 MG Oral Capsule	PSN	b0da7a68-29ff-48aa-a52d-e5b393f6b4f6	3
903291	benzonatate 150 MG Oral Capsule	PSN	7c210c0e-72b8-9656-e053-2991aa0a9455	3
903291	benzonatate 150 MG Oral Capsule	PSN	b0da7a68-29ff-48aa-a52d-e5b393f6b4f6	3
283417	benzonatate 200 MG Oral Capsule	PSN	7c210c0e-72b8-9656-e053-2991aa0a9455	3
283417	benzonatate 200 MG Oral Capsule	PSN	b0da7a68-29ff-48aa-a52d-e5b393f6b4f6	3
197397	benzonatate 100 MG Oral Capsule	SCD	7c210c0e-72b8-9656-e053-2991aa0a9455	3
197397	benzonatate 100 MG Oral Capsule	SCD	b0da7a68-29ff-48aa-a52d-e5b393f6b4f6	3
903291	benzonatate 150 MG Oral Capsule	SCD	7c210c0e-72b8-9656-e053-2991aa0a9455	3
903291	benzonatate 150 MG Oral Capsule	SCD	b0da7a68-29ff-48aa-a52d-e5b393f6b4f6	3
283417	benzonatate 200 MG Oral Capsule	SCD	7c210c0e-72b8-9656-e053-2991aa0a9455	3
283417	benzonatate 200 MG Oral Capsule	SCD	b0da7a68-29ff-48aa-a52d-e5b393f6b4f6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11788-027-01	11788002701	100 CAPSULE in 1 BOTTLE (11788-027-01)	100 capsule	2019-03-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	AiPing Pharmaceutical, Inc. \| Anshi Pharmaceutical (Zhongshan) Inc.	2022-10-22	HUMAN PRESCRIPTION DRUG LABEL	3
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	AiPing Pharmaceutical, Inc. \| Anshi Pharmaceutical (Zhongshan) Inc.	2020-06-30	HUMAN PRESCRIPTION DRUG LABEL	3