benzonatate

Product NDC
67296-1788
11-digit product format
672961788
Labeler code
67296
Product ID
67296-1788_afd8e604-072b-63d1-e053-2995a90a7682
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA040627
Marketing category
ANDA
Marketing start
2017-03-22
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
2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67296-1788IInactivated by FDA2026-08-17
excluded packagepackage67296-178867296-1788-7IInactivated by FDA2026-08-17

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-1788-7d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-1788-7f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-1788-72ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-1788-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-1788-7cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-1788-7cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-1788-7302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-1788-7ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-1788-70efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-1788-7ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-1788-7367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1788-7557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1788-78af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1788-7834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1788-71332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67296-1788-7fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67296-1788-786f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67296-1788-7bd6a592717d7…303034d00443…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040627-001BENZONATATEBENZONATATE100MGCAPSULE / ORALAA2007-03-30
A040627-002BENZONATATEBENZONATATE200MGCAPSULE / ORALAA2007-07-25
A040627-003BENZONATATEBENZONATATE150MGCAPSULE / ORALAARS2014-09-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040627-001AA
A040627-002AA
A040627-003AA

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07A040627-003BENZONATATE150MGCAPSULE / ORALAARS2014-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040627-003BENZONATATE150MGCAPSULE / ORALRS2014-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040627-003BENZONATATE150MGCAPSULE / ORALRS2014-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040627-003BENZONATATE150MGCAPSULE / ORALRS2014-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040627-003BENZONATATE150MGCAPSULE / ORALRS2014-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040627-003BENZONATATE150MGCAPSULE / ORALRS2014-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040627-001BENZONATATE100MGCAPSULE / ORALAA2007-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040627-002BENZONATATE200MGCAPSULE / ORALAA2007-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040627-003BENZONATATE150MGCAPSULE / ORALRS2014-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040627-002BENZONATATE200MGCAPSULE / ORAL2007-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040627-003BENZONATATE150MGCAPSULE / ORAL2014-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040627-002BENZONATATE200MGCAPSULE / ORAL2007-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040627-003BENZONATATE150MGCAPSULE / ORAL2014-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040627-002BENZONATATE200MGCAPSULE / ORAL2007-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040627-003BENZONATATE150MGCAPSULE / ORAL2014-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A040627-002BENZONATATE200MGCAPSULE / ORAL2007-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A040627-003BENZONATATE150MGCAPSULE / ORAL2014-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040627-002BENZONATATE200MGCAPSULE / ORAL2007-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040627-003BENZONATATE150MGCAPSULE / ORAL2014-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040627-002BENZONATATE200MGCAPSULE / ORAL2007-07-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040627-003BENZONATATE150MGCAPSULE / ORAL2014-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040627-001BENZONATATE100MGCAPSULE / ORAL2007-03-301e350fbaab3a…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040627-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040627-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A040627-003AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040627-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040627-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040627-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040627-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040627-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040627-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040627-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040627-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040627-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040627-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040627-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040627-002AA103ed91905a0d…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040627-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040627-002AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040627-003AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040627-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040627-002AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040627-003AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040627-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040627-002AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040627-003AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040627-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040627-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040627-002AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040627-003AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040627-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040627-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040627-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040627-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040627-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040627-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040627-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040627-001AA1ea99ee380514…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040627-001AA1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040627-002AA1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040627-003AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040627-001AA13f0d92c62455…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1788-72022-01-28C16284748780-1d6a99b39-e30f-a426-e053-dadaa90af4c2Benzonatate 100mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1788-7benzonatate15 in 1 BOTTLECAPSULE151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1788BENZONATATE CAPSULE [REDPHARM DRUG, INC.]1Legacy NDC, 1 package rows20200922_afd8e604-072a-63d1-e053-2995a90a7682.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
benzonatateBENZONATATEBryant Ranch Prepacka788cb01-6dc3-4f28-aaa0-c23ac058c39a2026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
BENZONATATEBENZONATATENorthwind Health Company, LLCda807eb3-349e-61b9-e053-2995a90a0e212026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
BENZONATATEBENZONATATEQPharma, Inc.55c4ae18-3e37-4caf-9fdb-9d307970b5f92025-12-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
BENZONATATEBENZONATATECoupler LLC463d5cff-3cd6-58fc-e063-6394a90a996b2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
BENZONATATEBENZONATATEAscend Laboratories, LLC54374c04-63b9-49fa-b6a2-4a711e322d8e2025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
benzonatateBENZONATATEProficient Rx LP9566b9b9-54ef-423c-8ce4-0f17140521582022-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
benzonatateBENZONATATEProficient Rx LP9fb78c06-e527-4596-884c-fcf882927a332020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627
benzonatateBENZONATATEBryant Ranch Prepack143a5ba8-0ee9-43be-a0da-2c455c1a46bd2019-09-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040627
application number: ANDA040627

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNafd8e604-072a-63d1-e053-2995a90a76821
197397benzonatate 100 MG Oral CapsuleSCDafd8e604-072a-63d1-e053-2995a90a76821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1788-76729617880715 CAPSULE in 1 BOTTLE (67296-1788-7) 15 capsule2017-03-220000-00-00NoNoCurrent