FDA.reportPublic FDA data

Benzonatate

Product NDC
65841-614
11-digit product format
658410614
Labeler code
65841
Product ID
65841-614_fb123061-e971-4394-aa10-ae733de31be1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA040597
Marketing category
ANDA
Marketing start
2007-09-04
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
65841-614-01Benzonatate100 in 1 BOTTLECAPSULE1009
65841-614-05Benzonatate500 in 1 BOTTLECAPSULE5009

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE ( BENZONATATE ) CAPSULE [CADILA HEALTHCARE LIMITED]2
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE ( BENZONATATE ) CAPSULE [CADILA HEALTHCARE LIMITED]2
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE ( BENZONATATE ) CAPSULE [CADILA HEALTHCARE LIMITED]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE ( BENZONATATE ) CAPSULE [CADILA HEALTHCARE LIMITED]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE ( BENZONATATE ) CAPSULE [CADILA HEALTHCARE LIMITED]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE ( BENZONATATE ) CAPSULE [CADILA HEALTHCARE LIMITED]2
SORBITOLINACTIVE INGREDIENT506T60A25RBENZONATATE ( BENZONATATE ) CAPSULE [CADILA HEALTHCARE LIMITED]2
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE ( BENZONATATE ) CAPSULE [CADILA HEALTHCARE LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-614BENZONATATE CAPSULE [ZYDUS LIFESCIENCES LIMITED]9Current NDC, Legacy NDC, 2 package rows20241128_abb4360a-4c52-45b6-9b80-df3c1bfc4c59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNabb4360a-4c52-45b6-9b80-df3c1bfc4c599
283417benzonatate 200 MG Oral CapsulePSNabb4360a-4c52-45b6-9b80-df3c1bfc4c599
197397benzonatate 100 MG Oral CapsuleSCDabb4360a-4c52-45b6-9b80-df3c1bfc4c599
283417benzonatate 200 MG Oral CapsuleSCDabb4360a-4c52-45b6-9b80-df3c1bfc4c599

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-614-0165841061401100 CAPSULE in 1 BOTTLE (65841-614-01) 100 capsule2007-09-040000-00-00NoNoCurrent
65841-614-0565841061405500 CAPSULE in 1 BOTTLE (65841-614-05) 500 capsule2007-09-040000-00-00NoNoCurrent