Benzonatate

Product NDC
71335-1544
11-digit product format
713351544
Labeler code
71335
Product ID
71335-1544_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
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
71335-1544-0Benzonatate10 in 1 BOTTLECAPSULE105
71335-1544-1Benzonatate30 in 1 BOTTLECAPSULE305
71335-1544-2Benzonatate20 in 1 BOTTLECAPSULE205
71335-1544-3Benzonatate100 in 1 BOTTLECAPSULE1005
71335-1544-4Benzonatate15 in 1 BOTTLECAPSULE155
71335-1544-5Benzonatate120 in 1 BOTTLECAPSULE1205
71335-1544-6Benzonatate60 in 1 BOTTLECAPSULE605
71335-1544-7Benzonatate90 in 1 BOTTLECAPSULE905
71335-1544-8Benzonatate14 in 1 BOTTLECAPSULE145
71335-1544-9Benzonatate40 in 1 BOTTLECAPSULE405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1544BENZONATATE CAPSULE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 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
71335-1544-07133515440010 CAPSULE in 1 BOTTLE (71335-1544-0) 10 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-17133515440130 CAPSULE in 1 BOTTLE (71335-1544-1) 30 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-27133515440220 CAPSULE in 1 BOTTLE (71335-1544-2) 20 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-371335154403100 CAPSULE in 1 BOTTLE (71335-1544-3) 100 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-47133515440415 CAPSULE in 1 BOTTLE (71335-1544-4) 15 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-571335154405120 CAPSULE in 1 BOTTLE (71335-1544-5) 120 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-67133515440660 CAPSULE in 1 BOTTLE (71335-1544-6) 60 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-77133515440790 CAPSULE in 1 BOTTLE (71335-1544-7) 90 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-87133515440814 CAPSULE in 1 BOTTLE (71335-1544-8) 14 capsule2020-03-250000-00-00NoNoCurrent
71335-1544-97133515440940 CAPSULE in 1 BOTTLE (71335-1544-9) 40 capsule2020-03-250000-00-00NoNoCurrent