Benzonatate

Product NDC
71335-2790
11-digit product format
713352790
Labeler code
71335
Product ID
71335-2790_bfae9fd9-1847-4503-9c29-85187a0fc39a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040597
Marketing category
ANDA
Marketing start
2007-04-09
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
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
BENZONATATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5P4DHS6ENR
Rxcui283417

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
71335-2790-1Benzonatate21 in 1 BOTTLECAPSULE211
71335-2790-2Benzonatate100 in 1 BOTTLECAPSULE1001
71335-2790-3Benzonatate500 in 1 BOTTLECAPSULE5001
71335-2790-4Benzonatate10 in 1 BOTTLECAPSULE101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSNb3b16ea5-4572-470e-8124-fc38b1d49e3e1
283417benzonatate 200 MG Oral CapsuleSCDb3b16ea5-4572-470e-8124-fc38b1d49e3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2790-17133527900121 CAPSULE in 1 BOTTLE (71335-2790-1) 21 capsule2026-03-11NoNoHistorical
71335-2790-271335279002100 CAPSULE in 1 BOTTLE (71335-2790-2) 100 capsule2026-03-11NoNoHistorical
71335-2790-371335279003500 CAPSULE in 1 BOTTLE (71335-2790-3) 500 capsule2026-03-11NoNoHistorical
71335-2790-47133527900410 CAPSULE in 1 BOTTLE (71335-2790-4) 10 capsule2026-03-11NoNoHistorical