FDA.reportPublic FDA data

benzonatate

Product NDC
46672-280
11-digit product format
466720280
Labeler code
46672
Product ID
46672-280_90a5231a-23ae-2638-e053-2a95a90acc37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Mikart, LLC
Application
ANDA040851
Marketing category
ANDA
Marketing start
2009-11-09
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
2020-12-31
Current FDA listing
Historical FDA.report record

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
A040851-001BENZONATATEBENZONATATE100MGCAPSULE / ORAL2009-11-09
A040851-002BENZONATATEBENZONATATE150MGCAPSULE / ORAL2009-11-09
A040851-003BENZONATATEBENZONATATE200MGCAPSULE / ORAL2009-11-09

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-09caaa826d4ba7…
2026-08-18 06:07:402026-07A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040851-002BENZONATATE150MGCAPSULE / ORAL2009-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040851-003BENZONATATE200MGCAPSULE / ORAL2009-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040851-001BENZONATATE100MGCAPSULE / ORAL2009-11-091e350fbaab3a…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04A040851-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040851-002AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040851-003AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040851-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040851-002AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040851-003AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040851-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040851-002AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040851-003AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040851-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040851-002AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040851-003AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040851-001AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040851-002AA1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040851-003AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040851-001AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040851-002AA187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040851-003AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040851-001AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040851-002AA15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040851-003AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040851-001AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040851-002AA18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040851-003AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040851-001AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040851-002AA1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040851-003AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040851-001AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A040851-002AA13f01610625f2…
2019-12-14 00:12 UTC2019-12A040851-003AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040851-001AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040851-002AA1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040851-003AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040851-001AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040851-002AA1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040851-003AA1ea99ee380514…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [MIKART, INC.]1
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [MIKART, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENZONATATE CAPSULE [MIKART, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BENZONATATE CAPSULE [MIKART, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHBENZONATATE CAPSULE [MIKART, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBENZONATATE CAPSULE [MIKART, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABENZONATATE CAPSULE [MIKART, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BENZONATATE CAPSULE [MIKART, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [MIKART, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FBENZONATATE CAPSULE [MIKART, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENZONATATE CAPSULE [MIKART, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [MIKART, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46672-280-1046672028010100 CAPSULE in 1 BOTTLE (46672-280-10) 100 capsule2009-11-090000-00-00NoNoCurrent
46672-280-5046672028050500 CAPSULE in 1 BOTTLE (46672-280-50) 500 capsule2009-11-090000-00-00NoNoCurrent