Benzonatate

Product NDC
68788-8329
11-digit product format
687888329
Labeler code
68788
Product ID
68788-8329_8107f64d-3336-46e7-b06c-e10c39d8beb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA206948
Marketing category
ANDA
Marketing start
2023-01-20
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206948-001BENZONATATEBENZONATATE100MGCAPSULE / ORALAARS2018-12-19
A206948-002BENZONATATEBENZONATATE200MGCAPSULE / ORALAARS2018-12-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206948-001AA
A206948-002AA

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19caaa826d4ba7…
2026-08-18 06:07:402026-07A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206948-001BENZONATATE100MGCAPSULE / ORALAARS2018-12-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206948-002BENZONATATE200MGCAPSULE / ORALAARS2018-12-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206948-001BENZONATATE100MGCAPSULE / ORALAA2018-12-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206948-002BENZONATATE200MGCAPSULE / ORALAA2018-12-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206948-001BENZONATATE100MGCAPSULE / ORALAA2018-12-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206948-002BENZONATATE200MGCAPSULE / ORALAA2018-12-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206948-001BENZONATATE100MGCAPSULE / ORALAA2018-12-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206948-002BENZONATATE200MGCAPSULE / ORALAA2018-12-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206948-001BENZONATATE100MGCAPSULE / ORALAA2018-12-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206948-002BENZONATATE200MGCAPSULE / ORALAA2018-12-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206948-001BENZONATATE100MGCAPSULE / ORALAA2018-12-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206948-002BENZONATATE200MGCAPSULE / ORALAA2018-12-19bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206948-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A206948-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206948-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206948-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206948-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206948-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206948-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206948-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206948-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206948-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206948-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206948-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206948-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206948-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206948-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206948-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206948-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206948-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206948-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206948-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206948-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206948-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206948-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206948-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206948-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206948-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206948-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206948-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206948-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206948-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206948-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206948-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206948-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206948-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206948-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206948-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206948-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206948-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206948-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206948-002AA1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZONATATE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5P4DHS6ENRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283417Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2cd05a6-2b8b-4731-b97b-b6677fbabbcfAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8329-1Benzonatate15 in 1 BOTTLECAPSULE154
68788-8329-2Benzonatate20 in 1 BOTTLECAPSULE204
68788-8329-3Benzonatate30 in 1 BOTTLECAPSULE304
68788-8329-6Benzonatate60 in 1 BOTTLECAPSULE604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8329-1EA - Each68788-8329f83acc8d-605d-4e0c-bc97-c0ebd8e2a24412023-02-06
68788-8329-2EA - Each68788-832978351acd-a396-46c4-ac49-137f58fd600612023-02-06
68788-8329-3EA - Each68788-8329179d0d56-7067-4fdc-8f5e-7792a55b6f2612023-02-06
68788-8329-6EA - Each68788-8329e3a5bf6d-b858-422d-8427-6b6f1066c26212023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8329BENZONATATE CAPSULE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250209_f2cd05a6-2b8b-4731-b97b-b6677fbabbcf.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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATEPD-Rx Pharmaceuticals, Inc.7a5460bf-5242-4726-9dfa-e215529842c32026-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEEpic Pharma LLC9b35e9d5-7d72-4f51-a245-ad2467ab40e92026-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEREMEDYREPACK INC.23a5de40-76d0-4117-8d31-2b2f8a6b0a282026-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEREMEDYREPACK INC.ed756746-4cbb-4196-a972-5a8c23702b2a2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEA-S Medication Solutionse6f5f2c2-1c59-405c-97bf-ee73740869d22026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEA-S Medication Solutions434130e1-c29c-4029-92c6-7d0f7a928e682026-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEMajor Pharmaceuticals324f65ae-09d1-4bd6-9d2b-593035201ecd2026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATESt. Mary's Medical Park Pharmacy96250e05-4608-7d5c-e053-2995a90ad57a2026-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATECardinal Health 107, LLCb46f231a-65d3-400d-ae6b-3216830807a22026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATESportpharm LLC0e8f2562-2449-430f-85bb-f9195644cdfa2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEPreferred Pharmaceuticals Inc3309040d-e240-42f6-9c51-5c54604a38962026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEPreferred Pharmaceuticals Inc.f2cd05a6-2b8b-4731-b97b-b6677fbabbcf2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
ndc (product): 68788-8329
BenzonatateBENZONATATEA-S Medication Solutions14550e43-1d1f-4dc1-a3f2-aac0d78a71182026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATENorthwind Health Company, LLCda6bcd14-2294-e7df-e053-2995a90a45262026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATENorthwind Health Company, LLCda6cead3-2859-df03-e053-2a95a90a010b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEQPharma Incfbd07fb0-c49c-a838-e053-6394a90a5f0e2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEAsclemed USA, Inc.25ed5206-b322-486f-9e54-14125f6e74c52025-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATERedPharm Drug, Inc.a2f6acff-70ff-79f1-e053-2a95a90a60052025-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEPD-Rx Pharmaceuticals, Inc.70e157f2-1670-422c-a70d-f9576e1647ea2025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948
BenzonatateBENZONATATEPD-Rx Pharmaceuticals, Inc.55b64aee-d4c4-4aad-9016-0dd879e979e62025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206948
application number: ANDA206948

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSNf2cd05a6-2b8b-4731-b97b-b6677fbabbcf4
283417benzonatate 200 MG Oral CapsuleSCDf2cd05a6-2b8b-4731-b97b-b6677fbabbcf4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8329-16878883290115 CAPSULE in 1 BOTTLE (68788-8329-1) 15 capsule2023-01-20NoNoCurrent
68788-8329-26878883290220 CAPSULE in 1 BOTTLE (68788-8329-2) 20 capsule2023-01-20NoNoCurrent
68788-8329-36878883290330 CAPSULE in 1 BOTTLE (68788-8329-3) 30 capsule2023-01-20NoNoCurrent
68788-8329-66878883290660 CAPSULE in 1 BOTTLE (68788-8329-6) 60 capsule2023-01-20NoNoCurrent