FDA.reportPublic FDA data

Benzonatate

Product NDC
42806-714
11-digit product format
428060714
Labeler code
42806
Product ID
42806-714_2b205287-dfba-75fe-e063-6294a90aee74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Epic Pharma LLC
Application
ANDA206948
Marketing category
ANDA
Marketing start
2018-12-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZONATATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5P4DHS6ENR
Rxcui197397, 283417

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
42806-714-01Benzonatate100 in 1 BOTTLECAPSULE1002
42806-714-05Benzonatate500 in 1 BOTTLECAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-714-01EA - Each42806-714c1c3478a-e367-42ee-b40d-1d41c92d0caa12019-06-19
42806-714-05EA - Each42806-71481d55112-cb74-43c6-b307-8a1a138163e512019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-714BENZONATATE CAPSULE [EPIC PHARMA LLC]2Current NDC, Legacy NDC, 2 package rows20250109_9b35e9d5-7d72-4f51-a245-ad2467ab40e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN23a5de40-76d0-4117-8d31-2b2f8a6b0a2816
197397benzonatate 100 MG Oral CapsuleSCD23a5de40-76d0-4117-8d31-2b2f8a6b0a2816
197397benzonatate 100 MG Oral CapsulePSN70e157f2-1670-422c-a70d-f9576e1647ea9
197397benzonatate 100 MG Oral CapsuleSCD70e157f2-1670-422c-a70d-f9576e1647ea9
197397benzonatate 100 MG Oral CapsulePSN3309040d-e240-42f6-9c51-5c54604a38968
197397benzonatate 100 MG Oral CapsuleSCD3309040d-e240-42f6-9c51-5c54604a38968
197397benzonatate 100 MG Oral CapsulePSNbec39717-eb88-6ca1-e053-2a95a90a9d9d6
283417benzonatate 200 MG Oral CapsulePSNbec39717-eb88-6ca1-e053-2a95a90a9d9d6
197397benzonatate 100 MG Oral CapsuleSCDbec39717-eb88-6ca1-e053-2a95a90a9d9d6
283417benzonatate 200 MG Oral CapsuleSCDbec39717-eb88-6ca1-e053-2a95a90a9d9d6
197397benzonatate 100 MG Oral CapsulePSN93f4935b-ba15-4a99-bfa9-96ca99a1ddc15
197397benzonatate 100 MG Oral CapsulePSN55b64aee-d4c4-4aad-9016-0dd879e979e65
283417benzonatate 200 MG Oral CapsulePSN93f4935b-ba15-4a99-bfa9-96ca99a1ddc15
197397benzonatate 100 MG Oral CapsuleSCD55b64aee-d4c4-4aad-9016-0dd879e979e65
197397benzonatate 100 MG Oral CapsuleSCD93f4935b-ba15-4a99-bfa9-96ca99a1ddc15
283417benzonatate 200 MG Oral CapsuleSCD93f4935b-ba15-4a99-bfa9-96ca99a1ddc15
197397benzonatate 100 MG Oral CapsulePSN324f65ae-09d1-4bd6-9d2b-593035201ecd4
197397benzonatate 100 MG Oral CapsulePSN94e0ac6f-8c5a-1fdb-e053-2a95a90a39464
197397benzonatate 100 MG Oral CapsulePSNda6bcd14-2294-e7df-e053-2995a90a45264
197397benzonatate 100 MG Oral CapsulePSNe6f5f2c2-1c59-405c-97bf-ee73740869d24
197397benzonatate 100 MG Oral CapsuleSCD94e0ac6f-8c5a-1fdb-e053-2a95a90a39464
197397benzonatate 100 MG Oral CapsuleSCDe6f5f2c2-1c59-405c-97bf-ee73740869d24
197397benzonatate 100 MG Oral CapsuleSCDda6bcd14-2294-e7df-e053-2995a90a45264
197397benzonatate 100 MG Oral CapsuleSCD324f65ae-09d1-4bd6-9d2b-593035201ecd4
197397benzonatate 100 MG Oral CapsulePSNa371479e-5219-a360-e053-2995a90a449d3
197397benzonatate 100 MG Oral CapsulePSN434130e1-c29c-4029-92c6-7d0f7a928e683
197397benzonatate 100 MG Oral CapsulePSNa2167f23-95bf-baa2-e053-2a95a90a7bbd3
197397benzonatate 100 MG Oral CapsuleSCDa371479e-5219-a360-e053-2995a90a449d3
197397benzonatate 100 MG Oral CapsuleSCD434130e1-c29c-4029-92c6-7d0f7a928e683
197397benzonatate 100 MG Oral CapsuleSCDa2167f23-95bf-baa2-e053-2a95a90a7bbd3
197397benzonatate 100 MG Oral CapsulePSN9b35e9d5-7d72-4f51-a245-ad2467ab40e92
197397benzonatate 100 MG Oral CapsulePSN25ed5206-b322-486f-9e54-14125f6e74c52
197397benzonatate 100 MG Oral CapsulePSN96250e05-4608-7d5c-e053-2995a90ad57a2
197397benzonatate 100 MG Oral CapsulePSN46b4f05c-9261-42fc-a016-c99eebab56462
283417benzonatate 200 MG Oral CapsulePSN9b35e9d5-7d72-4f51-a245-ad2467ab40e92
283417benzonatate 200 MG Oral CapsulePSN25ed5206-b322-486f-9e54-14125f6e74c52
197397benzonatate 100 MG Oral CapsuleSCD25ed5206-b322-486f-9e54-14125f6e74c52
197397benzonatate 100 MG Oral CapsuleSCD9b35e9d5-7d72-4f51-a245-ad2467ab40e92
197397benzonatate 100 MG Oral CapsuleSCD96250e05-4608-7d5c-e053-2995a90ad57a2
197397benzonatate 100 MG Oral CapsuleSCD46b4f05c-9261-42fc-a016-c99eebab56462
283417benzonatate 200 MG Oral CapsuleSCD25ed5206-b322-486f-9e54-14125f6e74c52
283417benzonatate 200 MG Oral CapsuleSCD9b35e9d5-7d72-4f51-a245-ad2467ab40e92
197397benzonatate 100 MG Oral CapsulePSN0e8f2562-2449-430f-85bb-f9195644cdfa1
197397benzonatate 100 MG Oral CapsulePSN477de03a-4439-42a3-9156-e440f1ab44211
283417benzonatate 200 MG Oral CapsulePSN0e8f2562-2449-430f-85bb-f9195644cdfa1
197397benzonatate 100 MG Oral CapsuleSCD477de03a-4439-42a3-9156-e440f1ab44211
197397benzonatate 100 MG Oral CapsuleSCD0e8f2562-2449-430f-85bb-f9195644cdfa1
283417benzonatate 200 MG Oral CapsuleSCD0e8f2562-2449-430f-85bb-f9195644cdfa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-714-0142806071401100 CAPSULE in 1 BOTTLE (42806-714-01) 100 capsule2018-12-210000-00-00NoNoCurrent
42806-714-0542806071405500 CAPSULE in 1 BOTTLE (42806-714-05) 500 capsule2018-12-210000-00-00NoNoCurrent