Benzonatate

Product NDC
71335-1553
11-digit product format
713351553
Labeler code
71335
Product ID
71335-1553_6a75cf59-91fe-4201-8c04-4b24dcad76e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-1553-1Benzonatate30 in 1 BOTTLECAPSULE305
71335-1553-2Benzonatate100 in 1 BOTTLECAPSULE1005
71335-1553-3Benzonatate45 in 1 BOTTLECAPSULE455
71335-1553-4Benzonatate20 in 1 BOTTLECAPSULE205
71335-1553-5Benzonatate15 in 1 BOTTLECAPSULE155
71335-1553-6Benzonatate21 in 1 BOTTLECAPSULE215
71335-1553-7Benzonatate60 in 1 BOTTLECAPSULE605
71335-1553-8Benzonatate50 in 1 BOTTLECAPSULE505
71335-1553-9Benzonatate90 in 1 BOTTLECAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1553BENZONATATE CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 9 package rows20240809_93f4935b-ba15-4a99-bfa9-96ca99a1ddc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1553-17133515530130 CAPSULE in 1 BOTTLE (71335-1553-1) 30 capsule2020-05-200000-00-00NoNoCurrent
71335-1553-271335155302100 CAPSULE in 1 BOTTLE (71335-1553-2) 100 capsule2020-05-200000-00-00NoNoCurrent
71335-1553-37133515530345 CAPSULE in 1 BOTTLE (71335-1553-3) 45 capsule2020-05-200000-00-00NoNoCurrent
71335-1553-47133515530420 CAPSULE in 1 BOTTLE (71335-1553-4) 20 capsule2020-05-200000-00-00NoNoCurrent
71335-1553-57133515530515 CAPSULE in 1 BOTTLE (71335-1553-5) 15 capsule2020-05-200000-00-00NoNoCurrent
71335-1553-67133515530621 CAPSULE in 1 BOTTLE (71335-1553-6) 21 capsule2020-05-200000-00-00NoNoCurrent
71335-1553-77133515530760 CAPSULE in 1 BOTTLE (71335-1553-7) 60 capsule2020-05-200000-00-00NoNoCurrent
71335-1553-87133515530850 CAPSULE in 1 BOTTLE (71335-1553-8) 50 capsule2020-05-200000-00-00NoNoCurrent
71335-1553-97133515530990 CAPSULE in 1 BOTTLE (71335-1553-9) 90 capsule2020-05-200000-00-00NoNoCurrent