FDA.reportPublic FDA data

Benzonatate

Product NDC
50090-5409
11-digit product format
500905409
Labeler code
50090
Product ID
50090-5409_351ba2ac-be0c-4273-bc32-fa70e90b883d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
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

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
50090-5409-0Benzonatate20 in 1 BOTTLECAPSULE204
50090-5409-1Benzonatate24 in 1 BOTTLECAPSULE244
50090-5409-2Benzonatate30 in 1 BOTTLECAPSULE304
50090-5409-5Benzonatate15 in 1 BOTTLECAPSULE154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5409-0EA - Each50090-5409da7ce917-94dc-4af4-a44d-39b298cc24ce12023-02-06
50090-5409-1EA - Each50090-5409df2899ac-bece-47e7-a5a7-f769835b403512023-02-06
50090-5409-2EA - Each50090-5409de3701e1-b6bf-4f15-afd3-48bf4ff8d38d12023-02-06
50090-5409-5EA - Each50090-54095531f2d9-76bf-459c-9fb7-769043033f0a12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5409BENZONATATE CAPSULE [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 4 package rows20231210_e6f5f2c2-1c59-405c-97bf-ee73740869d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNe6f5f2c2-1c59-405c-97bf-ee73740869d24
197397benzonatate 100 MG Oral CapsuleSCDe6f5f2c2-1c59-405c-97bf-ee73740869d24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5409-05009054090020 CAPSULE in 1 BOTTLE (50090-5409-0) 20 capsule2020-12-150000-00-00NoNoCurrent
50090-5409-15009054090124 CAPSULE in 1 BOTTLE (50090-5409-1) 24 capsule2020-12-150000-00-00NoNoCurrent
50090-5409-25009054090230 CAPSULE in 1 BOTTLE (50090-5409-2) 30 capsule2020-12-150000-00-00NoNoCurrent
50090-5409-55009054090515 CAPSULE in 1 BOTTLE (50090-5409-5) 15 capsule2020-12-150000-00-00NoNoCurrent