FDA.reportPublic FDA data

Benzonatate

Product NDC
50090-4969
11-digit product format
500904969
Labeler code
50090
Product ID
50090-4969_5c3c9630-b109-42fb-8a29-82707c036163
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202765
Marketing category
ANDA
Marketing start
2017-09-07
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4969-02023-02-07C16284748780-1f386c64a-2786-0266-e053-dadaa90a7c1aBenzonatate Capsules USP, 100 mg and 200 mg
50090-4969-12023-02-07C16284748780-1f386c64a-2786-0266-e053-dadaa90a7c1aBenzonatate Capsules USP, 100 mg and 200 mg
50090-4969-22023-02-07C16284748780-1f386c64a-2786-0266-e053-dadaa90a7c1aBenzonatate Capsules USP, 100 mg and 200 mg
50090-4969-52023-02-07C16284748780-1f386c64a-2786-0266-e053-dadaa90a7c1aBenzonatate Capsules USP, 100 mg and 200 mg
50090-4969-02023-01-30C16284748780-1f386c64a-2786-0266-e053-dadaa90a7c1aBenzonatate Capsules USP, 100 mg and 200 mg
50090-4969-12023-01-30C16284748780-1f386c64a-2786-0266-e053-dadaa90a7c1aBenzonatate Capsules USP, 100 mg and 200 mg
50090-4969-22023-01-30C16284748780-1f386c64a-2786-0266-e053-dadaa90a7c1aBenzonatate Capsules USP, 100 mg and 200 mg
50090-4969-52023-01-30C16284748780-1f386c64a-2786-0266-e053-dadaa90a7c1aBenzonatate Capsules USP, 100 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4969-0Benzonatate20 in 1 BOTTLECAPSULE205
50090-4969-1Benzonatate24 in 1 BOTTLECAPSULE245
50090-4969-2Benzonatate30 in 1 BOTTLECAPSULE305
50090-4969-5Benzonatate15 in 1 BOTTLECAPSULE155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4969-2EA - Each50090-4969462180b7-43b0-409d-904b-77fdb6a76ed212022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4969BENZONATATE CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 4 package rows20240130_cf41278a-3fb6-4bcb-b86e-016a41314625.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNcf41278a-3fb6-4bcb-b86e-016a413146255
197397benzonatate 100 MG Oral CapsuleSCDcf41278a-3fb6-4bcb-b86e-016a413146255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4969-05009049690020 CAPSULE in 1 BOTTLE (50090-4969-0) 20 capsule2020-03-170000-00-00NoNoCurrent
50090-4969-15009049690124 CAPSULE in 1 BOTTLE (50090-4969-1) 24 capsule2020-03-170000-00-00NoNoCurrent
50090-4969-25009049690230 CAPSULE in 1 BOTTLE (50090-4969-2) 30 capsule2020-03-170000-00-00NoNoCurrent
50090-4969-55009049690515 CAPSULE in 1 BOTTLE (50090-4969-5) 15 capsule2020-03-170000-00-00NoNoCurrent