BENZONATATE

Product NDC: 67877-575
Requested package NDC: 67877-575-01
11-digit product format: 678770575
Labeler code: 67877
Product ID: 67877-575_c4c367db-c1ef-4b68-b373-987b36e51f50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BENZONATATE
Dosage form: CAPSULE
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA040627
Marketing category: ANDA
Marketing start: 2017-03-22
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

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 · 10 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
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…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`

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	TE codes	RLD / RS	Approval date
A040627-001	BENZONATATE	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30
A040627-002	BENZONATATE	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25
A040627-003	BENZONATATE	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040627-001	AA
A040627-002	AA
A040627-003	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 · 108 observed 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
2026-08-18 06:07:40	2026-07	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL	AA	RS	2014-09-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL		RS	2014-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL		RS	2014-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL		RS	2014-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL		RS	2014-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL		RS	2014-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL	AA		2007-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL	AA		2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL		RS	2014-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL			2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL			2014-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL			2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL			2014-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL			2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL			2014-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL			2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL			2014-09-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL			2007-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL			2014-09-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040627-002	BENZONATATE	200MG	CAPSULE / ORAL			2007-07-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040627-003	BENZONATATE	150MG	CAPSULE / ORAL			2014-09-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040627-001	BENZONATATE	100MG	CAPSULE / ORAL			2007-03-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040627-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040627-002	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040627-003	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040627-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040627-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040627-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040627-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040627-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040627-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040627-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040627-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040627-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040627-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040627-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040627-002	AA	1	`03ed91905a0d…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040627-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040627-002	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040627-003	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040627-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040627-002	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040627-003	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040627-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040627-002	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040627-003	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040627-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040627-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040627-002	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040627-003	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040627-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040627-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040627-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040627-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040627-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040627-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040627-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040627-001	AA	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040627-001	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040627-002	AA	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040627-003	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040627-001	AA	1	`3f0d92c62455…`

Additional Listing Data#

Finished product: Yes
Brand name base: BENZONATATE
Listing expiration: 2026-12-31

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
54374c04-63b9-49fa-b6a2-4a711e322d8e	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, Related label table
NDC	Effective	Related label
67877-575-01	2024-11-23	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
67877-575-05	2024-11-23	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
67877-575-01	2021-07-23	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
67877-575-05	2021-07-23	Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67877-575-01	BENZONATATE	100 in 1 BOTTLE	CAPSULE	100		7
67877-575-05	BENZONATATE	500 in 1 BOTTLE	CAPSULE	500		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-575-01	EA - Each	67877-575	384a16db-309c-438b-9c82-c892e0d52100	1	2017-11-06
67877-575-05	EA - Each	67877-575	7596b9ab-846e-46ca-ae98-02c6a451c47f	1	2017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZONATATE	ACTIVE INGREDIENT	5P4DHS6ENR	BENZONATATE CAPSULE [DIRECT RX]	3
BENZONATATE	ACTIVE MOIETY	5P4DHS6ENR	BENZONATATE CAPSULE [DIRECT RX]	3
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	BENZONATATE CAPSULE [DIRECT RX]	3
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	BENZONATATE CAPSULE [DIRECT RX]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BENZONATATE CAPSULE [DIRECT RX]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	BENZONATATE CAPSULE [DIRECT RX]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BENZONATATE CAPSULE [DIRECT RX]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZONATATE CAPSULE [DIRECT RX]	3
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	BENZONATATE CAPSULE [DIRECT RX]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BENZONATATE CAPSULE [DIRECT RX]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	BENZONATATE CAPSULE [DIRECT RX]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENZONATATE CAPSULE [DIRECT RX]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZONATATE CAPSULE [DIRECT RX]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-575	BENZONATATE CAPSULE [ASCEND LABORATORIES, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241123_54374c04-63b9-49fa-b6a2-4a711e322d8e.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
benzonatate	BENZONATATE	Bryant Ranch Prepack	a788cb01-6dc3-4f28-aaa0-c23ac058c39a	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627
BENZONATATE	BENZONATATE	Northwind Health Company, LLC	da807eb3-349e-61b9-e053-2995a90a0e21	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627
BENZONATATE	BENZONATATE	QPharma, Inc.	55c4ae18-3e37-4caf-9fdb-9d307970b5f9	2025-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627
BENZONATATE	BENZONATATE	Coupler LLC	463d5cff-3cd6-58fc-e063-6394a90a996b	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627
BENZONATATE	BENZONATATE	Ascend Laboratories, LLC	54374c04-63b9-49fa-b6a2-4a711e322d8e	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627 ndc (package): 67877-575-01 ndc (product): 67877-575 ndc11 (package): 67877057501
benzonatate	BENZONATATE	Proficient Rx LP	9566b9b9-54ef-423c-8ce4-0f1714052158	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627
benzonatate	BENZONATATE	Proficient Rx LP	9fb78c06-e527-4596-884c-fcf882927a33	2020-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627
benzonatate	BENZONATATE	Bryant Ranch Prepack	143a5ba8-0ee9-43be-a0da-2c455c1a46bd	2019-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040627 application number: ANDA040627

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	54374c04-63b9-49fa-b6a2-4a711e322d8e	7
283417	benzonatate 200 MG Oral Capsule	PSN	54374c04-63b9-49fa-b6a2-4a711e322d8e	7
197397	benzonatate 100 MG Oral Capsule	SCD	54374c04-63b9-49fa-b6a2-4a711e322d8e	7
283417	benzonatate 200 MG Oral Capsule	SCD	54374c04-63b9-49fa-b6a2-4a711e322d8e	7
283417	benzonatate 200 MG Oral Capsule	PSN	9e1a2e84-c27a-4cb6-addb-cbe5d4b7d70e	6
283417	benzonatate 200 MG Oral Capsule	PSN	55c4ae18-3e37-4caf-9fdb-9d307970b5f9	6
283417	benzonatate 200 MG Oral Capsule	SCD	9e1a2e84-c27a-4cb6-addb-cbe5d4b7d70e	6
283417	benzonatate 200 MG Oral Capsule	SCD	55c4ae18-3e37-4caf-9fdb-9d307970b5f9	6
283417	benzonatate 200 MG Oral Capsule	PSN	2c3483d2-488d-41d9-9bfb-49e7dc64e307	5
283417	benzonatate 200 MG Oral Capsule	PSN	da807eb3-349e-61b9-e053-2995a90a0e21	5
283417	benzonatate 200 MG Oral Capsule	SCD	2c3483d2-488d-41d9-9bfb-49e7dc64e307	5
283417	benzonatate 200 MG Oral Capsule	SCD	da807eb3-349e-61b9-e053-2995a90a0e21	5
197397	benzonatate 100 MG Oral Capsule	PSN	a788cb01-6dc3-4f28-aaa0-c23ac058c39a	4
283417	benzonatate 200 MG Oral Capsule	PSN	27156dad-64d6-4ea4-a3da-29e8e096fb01	4
283417	benzonatate 200 MG Oral Capsule	PSN	a788cb01-6dc3-4f28-aaa0-c23ac058c39a	4
197397	benzonatate 100 MG Oral Capsule	SCD	a788cb01-6dc3-4f28-aaa0-c23ac058c39a	4
283417	benzonatate 200 MG Oral Capsule	SCD	27156dad-64d6-4ea4-a3da-29e8e096fb01	4
283417	benzonatate 200 MG Oral Capsule	SCD	a788cb01-6dc3-4f28-aaa0-c23ac058c39a	4
283417	benzonatate 200 MG Oral Capsule	PSN	6a100c5c-ec5e-29a3-e053-2991aa0aa3b0	3
283417	benzonatate 200 MG Oral Capsule	PSN	691cee22-9e7a-ffdb-e053-2a91aa0aa08e	3
283417	benzonatate 200 MG Oral Capsule	SCD	6a100c5c-ec5e-29a3-e053-2991aa0aa3b0	3
283417	benzonatate 200 MG Oral Capsule	SCD	691cee22-9e7a-ffdb-e053-2a91aa0aa08e	3
197397	benzonatate 100 MG Oral Capsule	PSN	9566b9b9-54ef-423c-8ce4-0f1714052158	2
283417	benzonatate 200 MG Oral Capsule	PSN	9566b9b9-54ef-423c-8ce4-0f1714052158	2
197397	benzonatate 100 MG Oral Capsule	SCD	9566b9b9-54ef-423c-8ce4-0f1714052158	2
283417	benzonatate 200 MG Oral Capsule	SCD	9566b9b9-54ef-423c-8ce4-0f1714052158	2
283417	benzonatate 200 MG Oral Capsule	PSN	1fda0d89-1c46-4411-9565-9546995998db	1
283417	benzonatate 200 MG Oral Capsule	SCD	1fda0d89-1c46-4411-9565-9546995998db	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-575-01	67877057501	100 CAPSULE in 1 BOTTLE (67877-575-01)	100 capsule	2017-03-22	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	Bryant Ranch Prepack	2026-05-28	HUMAN PRESCRIPTION DRUG LABEL	5
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	5
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	QPharma, Inc. \| Northwind Health Company, LLC	2025-12-21	HUMAN PRESCRIPTION DRUG LABEL	6
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Ascend Laboratories, LLC \| Softgel Healthcare Pvt. Ltd.	2025-12-02	Human Prescription Drug Label	7
benzonatate	RedPharm Drug, Inc.	2024-08-15	HUMAN PRESCRIPTION DRUG LABEL	3
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2023-12-13	HUMAN PRESCRIPTION DRUG LABEL	10
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	6
BENZONATATE	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
Benzonatate Capsules, USP 100 mg and 200 mg	Proficient Rx LP	2022-05-01	HUMAN PRESCRIPTION DRUG LABEL	2
Benzonatate Capsules, USP 200 mg	PD-Rx Pharmaceuticals, Inc.	2021-12-09	HUMAN PRESCRIPTION DRUG LABEL	7
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	A-S Medication Solutions	2021-08-07	HUMAN PRESCRIPTION DRUG LABEL	11
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Preferred Pharmaceuticals Inc	2021-03-19	HUMAN PRESCRIPTION DRUG LABEL	5
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	QPharma Inc \| Ascend Laboratories LLC \| Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	3
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	NuCare Pharmaceuticals,Inc.	2021-02-16	HUMAN PRESCRIPTION DRUG LABEL	4
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-04	HUMAN PRESCRIPTION DRUG LABEL	3
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	4
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	3
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Proficient Rx LP	2020-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	REMEDYREPACK INC.	2019-09-11	HUMAN PRESCRIPTION DRUG LABEL	4
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Bryant Ranch Prepack	2019-09-11	HUMAN PRESCRIPTION DRUG LABEL	2
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Liberty Pharmaceuticals, Inc. \| Proficient Rx LP	2019-09-01	HUMAN PRESCRIPTION DRUG LABEL	1
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Bryant Ranch Prepack	2019-06-13	HUMAN PRESCRIPTION DRUG LABEL	2
Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg	Lake Erie Medical DBA Quality Care Products LLC	2019-05-14	HUMAN PRESCRIPTION DRUG LABEL	2
BENZONATATE	DIRECT RX	2019-04-03	HUMAN PRESCRIPTION DRUG LABEL	5