Benzonatate

Product NDC
71335-3068
11-digit product format
713353068
Labeler code
71335
Product ID
71335-3068_c238e488-1abe-4864-917b-fa25c45822e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202765
Marketing category
ANDA
Marketing start
2024-07-26
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
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
71335-3068-0Benzonatate10 in 1 BOTTLECAPSULE101
71335-3068-1Benzonatate30 in 1 BOTTLECAPSULE301
71335-3068-2Benzonatate20 in 1 BOTTLECAPSULE201
71335-3068-3Benzonatate100 in 1 BOTTLECAPSULE1001
71335-3068-4Benzonatate15 in 1 BOTTLECAPSULE151
71335-3068-5Benzonatate120 in 1 BOTTLECAPSULE1201
71335-3068-6Benzonatate60 in 1 BOTTLECAPSULE601
71335-3068-7Benzonatate90 in 1 BOTTLECAPSULE901
71335-3068-8Benzonatate14 in 1 BOTTLECAPSULE141
71335-3068-9Benzonatate40 in 1 BOTTLECAPSULE401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNe1bf84c8-fc88-4f43-8655-7ce95a4da51f1
197397benzonatate 100 MG Oral CapsuleSCDe1bf84c8-fc88-4f43-8655-7ce95a4da51f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3068-07133530680010 CAPSULE in 1 BOTTLE (71335-3068-0) 10 capsule2026-02-06NoNoHistorical
71335-3068-17133530680130 CAPSULE in 1 BOTTLE (71335-3068-1) 30 capsule2026-02-06NoNoHistorical
71335-3068-27133530680220 CAPSULE in 1 BOTTLE (71335-3068-2) 20 capsule2026-02-06NoNoHistorical
71335-3068-371335306803100 CAPSULE in 1 BOTTLE (71335-3068-3) 100 capsule2026-02-06NoNoHistorical
71335-3068-47133530680415 CAPSULE in 1 BOTTLE (71335-3068-4) 15 capsule2026-02-06NoNoHistorical
71335-3068-571335306805120 CAPSULE in 1 BOTTLE (71335-3068-5) 120 capsule2026-02-06NoNoHistorical
71335-3068-67133530680660 CAPSULE in 1 BOTTLE (71335-3068-6) 60 capsule2026-02-06NoNoHistorical
71335-3068-77133530680790 CAPSULE in 1 BOTTLE (71335-3068-7) 90 capsule2026-02-06NoNoHistorical
71335-3068-87133530680814 CAPSULE in 1 BOTTLE (71335-3068-8) 14 capsule2026-02-06NoNoHistorical
71335-3068-97133530680940 CAPSULE in 1 BOTTLE (71335-3068-9) 40 capsule2026-02-06NoNoHistorical