FDA.reportPublic FDA data

Benzonatate

Product NDC
42806-715
11-digit product format
428060715
Labeler code
42806
Product ID
42806-715_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
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZONATATE200 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
42806-715-01Benzonatate100 in 1 BOTTLECAPSULE1002
42806-715-05Benzonatate500 in 1 BOTTLECAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-715-01EA - Each42806-715cc62b42b-af86-4fb3-b037-75f8bc16c14012019-06-19
42806-715-05EA - Each42806-715f97a75a1-d803-4a81-8bd8-ddd1ea2643a712019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-715BENZONATATE 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
283417benzonatate 200 MG Oral CapsulePSNed756746-4cbb-4196-a972-5a8c23702b2a15
283417benzonatate 200 MG Oral CapsuleSCDed756746-4cbb-4196-a972-5a8c23702b2a15
197397benzonatate 100 MG Oral CapsulePSNbec39717-eb88-6ca1-e053-2a95a90a9d9d6
283417benzonatate 200 MG Oral CapsulePSN7a5460bf-5242-4726-9dfa-e215529842c36
283417benzonatate 200 MG Oral CapsulePSN14550e43-1d1f-4dc1-a3f2-aac0d78a71186
283417benzonatate 200 MG Oral CapsulePSNbec39717-eb88-6ca1-e053-2a95a90a9d9d6
197397benzonatate 100 MG Oral CapsuleSCDbec39717-eb88-6ca1-e053-2a95a90a9d9d6
283417benzonatate 200 MG Oral CapsuleSCD14550e43-1d1f-4dc1-a3f2-aac0d78a71186
283417benzonatate 200 MG Oral CapsuleSCD7a5460bf-5242-4726-9dfa-e215529842c36
283417benzonatate 200 MG Oral CapsuleSCDbec39717-eb88-6ca1-e053-2a95a90a9d9d6
197397benzonatate 100 MG Oral CapsulePSN93f4935b-ba15-4a99-bfa9-96ca99a1ddc15
283417benzonatate 200 MG Oral CapsulePSN93f4935b-ba15-4a99-bfa9-96ca99a1ddc15
197397benzonatate 100 MG Oral CapsuleSCD93f4935b-ba15-4a99-bfa9-96ca99a1ddc15
283417benzonatate 200 MG Oral CapsuleSCD93f4935b-ba15-4a99-bfa9-96ca99a1ddc15
283417benzonatate 200 MG Oral CapsulePSNf2cd05a6-2b8b-4731-b97b-b6677fbabbcf4
283417benzonatate 200 MG Oral CapsulePSNa8f5bdb6-677b-416c-834e-60307b566bd74
283417benzonatate 200 MG Oral CapsulePSN941afb1f-348b-4340-e053-2995a90ac3704
283417benzonatate 200 MG Oral CapsulePSNa2f6acff-70ff-79f1-e053-2a95a90a60054
283417benzonatate 200 MG Oral CapsuleSCDa8f5bdb6-677b-416c-834e-60307b566bd74
283417benzonatate 200 MG Oral CapsuleSCDa2f6acff-70ff-79f1-e053-2a95a90a60054
283417benzonatate 200 MG Oral CapsuleSCD941afb1f-348b-4340-e053-2995a90ac3704
283417benzonatate 200 MG Oral CapsuleSCDf2cd05a6-2b8b-4731-b97b-b6677fbabbcf4
283417benzonatate 200 MG Oral CapsulePSNfbd07fb0-c49c-a838-e053-6394a90a5f0e3
283417benzonatate 200 MG Oral CapsuleSCDfbd07fb0-c49c-a838-e053-6394a90a5f0e3
197397benzonatate 100 MG Oral CapsulePSN9b35e9d5-7d72-4f51-a245-ad2467ab40e92
197397benzonatate 100 MG Oral CapsulePSN25ed5206-b322-486f-9e54-14125f6e74c52
283417benzonatate 200 MG Oral CapsulePSN9b35e9d5-7d72-4f51-a245-ad2467ab40e92
283417benzonatate 200 MG Oral CapsulePSNda6cead3-2859-df03-e053-2a95a90a010b2
283417benzonatate 200 MG Oral CapsulePSN25ed5206-b322-486f-9e54-14125f6e74c52
197397benzonatate 100 MG Oral CapsuleSCD9b35e9d5-7d72-4f51-a245-ad2467ab40e92
197397benzonatate 100 MG Oral CapsuleSCD25ed5206-b322-486f-9e54-14125f6e74c52
283417benzonatate 200 MG Oral CapsuleSCD9b35e9d5-7d72-4f51-a245-ad2467ab40e92
283417benzonatate 200 MG Oral CapsuleSCDda6cead3-2859-df03-e053-2a95a90a010b2
283417benzonatate 200 MG Oral CapsuleSCD25ed5206-b322-486f-9e54-14125f6e74c52
197397benzonatate 100 MG Oral CapsulePSN0e8f2562-2449-430f-85bb-f9195644cdfa1
283417benzonatate 200 MG Oral CapsulePSNa94c345f-9701-4434-a445-1b12f711e1491
283417benzonatate 200 MG Oral CapsulePSN0e8f2562-2449-430f-85bb-f9195644cdfa1
197397benzonatate 100 MG Oral CapsuleSCD0e8f2562-2449-430f-85bb-f9195644cdfa1
283417benzonatate 200 MG Oral CapsuleSCDa94c345f-9701-4434-a445-1b12f711e1491
283417benzonatate 200 MG Oral CapsuleSCD0e8f2562-2449-430f-85bb-f9195644cdfa1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-715-0142806071501100 CAPSULE in 1 BOTTLE (42806-715-01) 100 capsule2018-12-210000-00-00NoNoCurrent
42806-715-0542806071505500 CAPSULE in 1 BOTTLE (42806-715-05) 500 capsule2018-12-210000-00-00NoNoCurrent