Benzonatate

Product NDC
71335-1968
11-digit product format
713351968
Labeler code
71335
Product ID
71335-1968_db58683b-93e6-49ac-a724-7ca687e17fee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1968-0Benzonatate10 in 1 BOTTLECAPSULE10104
71335-1968-1Benzonatate30 in 1 BOTTLECAPSULE30104
71335-1968-2Benzonatate20 in 1 BOTTLECAPSULE20104
71335-1968-3Benzonatate100 in 1 BOTTLECAPSULE100104
71335-1968-4Benzonatate15 in 1 BOTTLECAPSULE15104
71335-1968-5Benzonatate120 in 1 BOTTLECAPSULE120104
71335-1968-6Benzonatate60 in 1 BOTTLECAPSULE60104
71335-1968-7Benzonatate90 in 1 BOTTLECAPSULE90104
71335-1968-8Benzonatate14 in 1 BOTTLECAPSULE14104
71335-1968-9Benzonatate40 in 1 BOTTLECAPSULE40104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1968BENZONATATE CAPSULE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20240524_5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f104
197397benzonatate 100 MG Oral CapsuleSCD5add9fd2-5f54-4669-b82a-0e0a8fcd5a8f104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1968-07133519680010 CAPSULE in 1 BOTTLE (71335-1968-0) 10 capsule2022-09-280000-00-00NoNoCurrent
71335-1968-17133519680130 CAPSULE in 1 BOTTLE (71335-1968-1) 30 capsule2021-10-260000-00-00NoNoCurrent
71335-1968-27133519680220 CAPSULE in 1 BOTTLE (71335-1968-2) 20 capsule2021-11-080000-00-00NoNoCurrent
71335-1968-371335196803100 CAPSULE in 1 BOTTLE (71335-1968-3) 100 capsule2022-09-280000-00-00NoNoCurrent
71335-1968-47133519680415 CAPSULE in 1 BOTTLE (71335-1968-4) 15 capsule2022-04-280000-00-00NoNoCurrent
71335-1968-571335196805120 CAPSULE in 1 BOTTLE (71335-1968-5) 120 capsule2022-09-280000-00-00NoNoCurrent
71335-1968-67133519680660 CAPSULE in 1 BOTTLE (71335-1968-6) 60 capsule2022-09-280000-00-00NoNoCurrent
71335-1968-77133519680790 CAPSULE in 1 BOTTLE (71335-1968-7) 90 capsule2021-11-040000-00-00NoNoCurrent
71335-1968-87133519680814 CAPSULE in 1 BOTTLE (71335-1968-8) 14 capsule2022-09-280000-00-00NoNoCurrent
71335-1968-97133519680940 CAPSULE in 1 BOTTLE (71335-1968-9) 40 capsule2022-09-280000-00-00NoNoCurrent