Benzonatate

Product NDC: 68071-5156
Requested package NDC: 68071-5156-2
11-digit product format: 680715156
Labeler code: 68071
Product ID: 68071-5156_1b563e5b-e6c5-52d7-e063-6294a90a4aa9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA081297
Marketing category: ANDA
Marketing start: 2016-08-15
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

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-5156	68071-5156-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-5156	68071-5156-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-5156	68071-5156-2	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
A081297-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA		1993-01-29
A081297-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A081297-001	AA
A081297-002	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	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA	1993-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA	2007-10-30	`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	A081297-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A081297-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081297-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081297-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081297-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A081297-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081297-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081297-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081297-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081297-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081297-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081297-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081297-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081297-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081297-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081297-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081297-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081297-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081297-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A081297-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081297-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081297-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081297-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081297-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081297-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081297-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081297-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A081297-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081297-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081297-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081297-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A081297-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081297-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A081297-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081297-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A081297-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081297-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A081297-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081297-001	AA	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A081297-002	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
9cab4544-e0ab-3fdd-e053-2995a90ad049	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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5156-2	2024-06-20	C162847	48780-1	f386c649-eb4b-0266-e053-dadaa90a7c1a	BENZONATATE CAPSULES USP, 100 mg and 200 mg
68071-5156-2	2023-01-30	C162847	48780-1	f386c649-eb4b-0266-e053-dadaa90a7c1a	BENZONATATE CAPSULES USP, 100 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-5156-2	Benzonatate	20 in 1 BOTTLE	CAPSULE	20		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5156	BENZONATATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240621_9cab4544-e0ab-3fdd-e053-2995a90ad049.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benzonatate	BENZONATATE	Bryant Ranch Prepack	5728b147-33a0-4534-b936-3e02274d9467	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297
Benzonatate	BENZONATATE	Golden State Medical Supply, Inc.	d580b1c9-d450-4032-acb2-0563c589ed2c	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297
Benzonatate	BENZONATATE	Bionpharma Inc.	2630be01-1d2d-4c40-8e56-8568ea89eacf	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297
Benzonatate	BENZONATATE	Bryant Ranch Prepack	540d2bc6-11dc-43d7-b616-b89d75b81cd1	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297
Benzonatate	BENZONATATE	Coupler LLC	2ce035ff-42cb-d8ef-e063-6294a90a0c06	2025-01-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297
Benzonatate	BENZONATATE	NuCare Pharmaceuticals,Inc.	9cab4544-e0ab-3fdd-e053-2995a90ad049	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297 ndc (package): 68071-5156-2 ndc (product): 68071-5156 ndc11 (package): 68071515602
Benzonatate	BENZONATATE	NuCare Pharmaceuticals,Inc.	96b260c3-e177-73c3-e053-2a95a90a775e	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297
Benzonatate	BENZONATATE	Aphena Pharma Solutions - Tennessee, LLC	3bd33aec-9a30-4581-bd28-6cfb67772cef	2023-03-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297
Benzonatate	BENZONATATE	Proficient Rx LP	bc435603-ddc4-4083-af09-2e562defbe7f	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297
Benzonatate	BENZONATATE	Proficient Rx LP	0d14cbf4-f43f-4ad2-8e8b-7a844e417702	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 081297 application number: ANDA081297

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	9cab4544-e0ab-3fdd-e053-2995a90ad049	3
197397	benzonatate 100 MG Oral Capsule	SCD	9cab4544-e0ab-3fdd-e053-2995a90ad049	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5156-2	68071515602	20 CAPSULE in 1 BOTTLE (68071-5156-2)	20 capsule	2020-01-21	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	NuCare Pharmaceuticals,Inc.	2024-06-20	HUMAN PRESCRIPTION DRUG LABEL	3