Benzonatate

Product NDC
68084-214
11-digit product format
680840214
Labeler code
68084
Product ID
68084-214_235a2641-ce68-1f9c-e063-6394a90ac8a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040597
Marketing category
ANDA
Marketing start
2021-05-26
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
68084-214-01Benzonatate10 in 1 CARTONCAPSULE105
68084-214-11Benzonatate10 in 1 BLISTER PACKCAPSULE105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-214-01EA - Each68084-214d0695799-d881-4623-8662-55470b4562c512012-07-24
68084-214-11EA - Each68084-214e24d16b0-de80-4680-89be-432eb663605e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
SORBITOLINACTIVE INGREDIENT506T60A25RBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-214BENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20241001_9a71725a-64b6-4800-a79c-aa4b2d74d44f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN9a71725a-64b6-4800-a79c-aa4b2d74d44f5
197397benzonatate 100 MG Oral CapsuleSCD9a71725a-64b6-4800-a79c-aa4b2d74d44f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-214-016808402140110 BLISTER PACK in 1 CARTON (68084-214-01) / 10 CAPSULE in 1 BLISTER PACK (68084-214-11) 10 blister pack2021-05-260000-00-00NoNoCurrent
68084-214-116808402141110 in 1 BLISTER PACKHistorical