Benzonatate

Product NDC: 69452-144
11-digit product format: 694520144
Labeler code: 69452
Product ID: 69452-144_407f50b2-8640-399e-e063-6294a90a4e2a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Benzonatate
Dosage form: CAPSULE
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA081297
Marketing category: ANDA
Marketing start: 2016-08-15
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
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.

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
2026-08-01 22:54:32	2026-06	A081297-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		1993-01-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A081297-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-10-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A081297-001	AA	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A081297-002	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 69452-144
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
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

Additional Listing Data#

Finished product: Yes
Brand name base: Benzonatate
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197397	Internal RxNorm lookup
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
2630be01-1d2d-4c40-8e56-8568ea89eacf	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
69452-144-20	Benzonatate	100 in 1 BOTTLE, PLASTIC	CAPSULE	100		6
69452-144-30	Benzonatate	500 in 1 BOTTLE, PLASTIC	CAPSULE	500		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-144-20	EA - Each	69452-144	15fa785c-0ec3-48dc-b411-ddb9bf860b78	1	2016-12-07
69452-144-30	EA - Each	69452-144	84148c41-e8a4-489e-a42d-b4eb01632414	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-144	BENZONATATE CAPSULE [BIONPHARMA INC.]	5	Current NDC, Legacy NDC, 2 package rows	20241218_2630be01-1d2d-4c40-8e56-8568ea89eacf.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
283417	benzonatate 200 MG Oral Capsule	PSN	5728b147-33a0-4534-b936-3e02274d9467	102
283417	benzonatate 200 MG Oral Capsule	SCD	5728b147-33a0-4534-b936-3e02274d9467	102
197397	benzonatate 100 MG Oral Capsule	PSN	d580b1c9-d450-4032-acb2-0563c589ed2c	8
283417	benzonatate 200 MG Oral Capsule	PSN	d580b1c9-d450-4032-acb2-0563c589ed2c	8
197397	benzonatate 100 MG Oral Capsule	SCD	d580b1c9-d450-4032-acb2-0563c589ed2c	8
283417	benzonatate 200 MG Oral Capsule	SCD	d580b1c9-d450-4032-acb2-0563c589ed2c	8
197397	benzonatate 100 MG Oral Capsule	PSN	2630be01-1d2d-4c40-8e56-8568ea89eacf	6
283417	benzonatate 200 MG Oral Capsule	PSN	2630be01-1d2d-4c40-8e56-8568ea89eacf	6
197397	benzonatate 100 MG Oral Capsule	SCD	2630be01-1d2d-4c40-8e56-8568ea89eacf	6
283417	benzonatate 200 MG Oral Capsule	SCD	2630be01-1d2d-4c40-8e56-8568ea89eacf	6
283417	benzonatate 200 MG Oral Capsule	PSN	63c4ebf2-37b9-4c90-a082-a24c8373a85a	5
283417	benzonatate 200 MG Oral Capsule	SCD	63c4ebf2-37b9-4c90-a082-a24c8373a85a	5
283417	benzonatate 200 MG Oral Capsule	PSN	bc435603-ddc4-4083-af09-2e562defbe7f	2
283417	benzonatate 200 MG Oral Capsule	SCD	bc435603-ddc4-4083-af09-2e562defbe7f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-144-20	69452014420	100 CAPSULE in 1 BOTTLE, PLASTIC (69452-144-20)	100 capsule	2016-08-15	0000-00-00	No	No	Current
69452-144-30	69452014430	500 CAPSULE in 1 BOTTLE, PLASTIC (69452-144-30)	500 capsule	2016-08-15	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	2026-07-15	HUMAN PRESCRIPTION DRUG LABEL	103
BENZONATATE CAPSULES USP, 100 mg and 200 mg	Golden State Medical Supply, Inc.	2026-07-06	HUMAN PRESCRIPTION DRUG LABEL	9
BENZONATATE CAPSULES USP, 100 mg and 200 mg	Bionpharma Inc. \| Patheon Softgels Inc. \| ESJAY PHARMA PRIVATE LIMITED	2026-06-23	HUMAN PRESCRIPTION DRUG LABEL	7
BENZONATATE CAPSULES USP, 100 mg and 200 mg	Bryant Ranch Prepack	2025-02-04	HUMAN PRESCRIPTION DRUG LABEL	101
BENZONATATE CAPSULES USP 200 mg	Pharmasource Meds, LLC	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	2
BENZONATATE CAPSULES USP, 100 mg and 200 mg	Bryant Ranch Prepack	2024-01-11	HUMAN PRESCRIPTION DRUG LABEL	102
BENZONATATE CAPSULES USP, 100 mg and 200 mg	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	5
BENZONATATE CAPSULES USP, 100 mg and 200 mg	Preferred Pharmaceuticals Inc..	2023-04-06	HUMAN PRESCRIPTION DRUG LABEL	2
BENZONATATE CAPSULES USP, 200 mg	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2023-01-03	HUMAN PRESCRIPTION DRUG LABEL	2
BENZONATATE CAPSULES USP, 200 mg	Proficient Rx LP	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	2