Benzonatate

Product NDC
71335-1927
11-digit product format
713351927
Labeler code
71335
Product ID
71335-1927_45902888-6422-4ada-8cc1-a44d76468ae5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA081297
Marketing category
ANDA
Marketing start
2016-08-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benzonatate
Listing expiration
2027-12-31

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
71335-1927-0Benzonatate10 in 1 BOTTLE, PLASTICCAPSULE10104
71335-1927-1Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE30104
71335-1927-2Benzonatate20 in 1 BOTTLE, PLASTICCAPSULE20104
71335-1927-3Benzonatate100 in 1 BOTTLE, PLASTICCAPSULE100104
71335-1927-4Benzonatate15 in 1 BOTTLE, PLASTICCAPSULE15104
71335-1927-5Benzonatate120 in 1 BOTTLE, PLASTICCAPSULE120104
71335-1927-6Benzonatate60 in 1 BOTTLE, PLASTICCAPSULE60104
71335-1927-7Benzonatate90 in 1 BOTTLE, PLASTICCAPSULE90104
71335-1927-8Benzonatate14 in 1 BOTTLE, PLASTICCAPSULE14104
71335-1927-9Benzonatate40 in 1 BOTTLE, PLASTICCAPSULE40104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1927BENZONATATE CAPSULE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 10 package rows20250226_540d2bc6-11dc-43d7-b616-b89d75b81cd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN540d2bc6-11dc-43d7-b616-b89d75b81cd1104
197397benzonatate 100 MG Oral CapsuleSCD540d2bc6-11dc-43d7-b616-b89d75b81cd1104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1927-07133519270010 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-0) 10 capsule2025-01-300000-00-00NoNoCurrent
71335-1927-17133519270130 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-1) 30 capsule2021-07-290000-00-00NoNoCurrent
71335-1927-27133519270220 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-2) 20 capsule2021-08-040000-00-00NoNoCurrent
71335-1927-371335192703100 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-3) 100 capsule2025-01-300000-00-00NoNoCurrent
71335-1927-47133519270415 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-4) 15 capsule2021-08-030000-00-00NoNoCurrent
71335-1927-571335192705120 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-5) 120 capsule2025-01-300000-00-00NoNoCurrent
71335-1927-67133519270660 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-6) 60 capsule2025-01-300000-00-00NoNoCurrent
71335-1927-77133519270790 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-7) 90 capsule2025-01-300000-00-00NoNoCurrent
71335-1927-87133519270814 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-8) 14 capsule2025-01-300000-00-00NoNoCurrent
71335-1927-97133519270940 CAPSULE in 1 BOTTLE, PLASTIC (71335-1927-9) 40 capsule2025-01-300000-00-00NoNoCurrent