FDA.reportPublic FDA data

Benzonatate

Product NDC
71335-0091
11-digit product format
713350091
Labeler code
71335
Product ID
71335-0091_f721a18a-c457-4c4a-98de-2288d21916a7
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
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
71335-0091-0Benzonatate10 in 1 BOTTLECAPSULE105
71335-0091-1Benzonatate30 in 1 BOTTLECAPSULE305
71335-0091-2Benzonatate20 in 1 BOTTLECAPSULE205
71335-0091-3Benzonatate100 in 1 BOTTLECAPSULE1005
71335-0091-4Benzonatate15 in 1 BOTTLECAPSULE155
71335-0091-5Benzonatate120 in 1 BOTTLECAPSULE1205
71335-0091-6Benzonatate60 in 1 BOTTLECAPSULE605
71335-0091-7Benzonatate90 in 1 BOTTLECAPSULE905
71335-0091-8Benzonatate14 in 1 BOTTLECAPSULE145
71335-0091-9Benzonatate40 in 1 BOTTLECAPSULE405

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0091-1EA - Each71335-009105ee9982-546a-4a71-b54d-88f48c05b1d912018-03-08
71335-0091-2EA - Each71335-0091d8746383-483e-48ee-b900-2cdedaa1124812018-03-08
71335-0091-3EA - Each71335-0091a29281fc-8424-4bec-8fd3-d66a30cb8dd812018-03-08
71335-0091-4EA - Each71335-0091e8ee14fb-2bbd-48bd-be48-7fdb77d8b6cf12018-03-08
71335-0091-5EA - Each71335-009141abc5f4-04fd-46f8-9f98-e504e0ddbee812018-03-08
71335-0091-6EA - Each71335-0091f8984682-148f-4d34-aabe-1109f4ef7a6d12018-03-08
71335-0091-7EA - Each71335-0091b2b3b200-4188-4f8f-bdf4-fada7051c2e912018-03-08
71335-0091-8EA - Each71335-009117ef6ac4-21ea-476e-b329-8df1150a0c8712018-03-08
71335-0091-9EA - Each71335-009193f55d9b-8b97-4b1a-8f09-8e75b2fbbc4c12018-03-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN751d9d60-cd6b-4aa1-b68f-61b86c4059ad5
197397benzonatate 100 MG Oral CapsuleSCD751d9d60-cd6b-4aa1-b68f-61b86c4059ad5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-0091-07133500910010 CAPSULE in 1 BOTTLE (71335-0091-0) 10 capsule2019-04-30NoNoCurrent
71335-0091-17133500910130 CAPSULE in 1 BOTTLE (71335-0091-1) 30 capsule2019-04-30NoNoCurrent
71335-0091-27133500910220 CAPSULE in 1 BOTTLE (71335-0091-2) 20 capsule2019-04-30NoNoCurrent
71335-0091-371335009103100 CAPSULE in 1 BOTTLE (71335-0091-3) 100 capsule2019-04-30NoNoCurrent
71335-0091-47133500910415 CAPSULE in 1 BOTTLE (71335-0091-4) 15 capsule2019-04-30NoNoCurrent
71335-0091-571335009105120 CAPSULE in 1 BOTTLE (71335-0091-5) 120 capsule2019-04-30NoNoCurrent
71335-0091-67133500910660 CAPSULE in 1 BOTTLE (71335-0091-6) 60 capsule2019-04-30NoNoCurrent
71335-0091-77133500910790 CAPSULE in 1 BOTTLE (71335-0091-7) 90 capsule2019-04-30NoNoCurrent
71335-0091-87133500910814 CAPSULE in 1 BOTTLE (71335-0091-8) 14 capsule2019-04-30NoNoCurrent
71335-0091-97133500910940 CAPSULE in 1 BOTTLE (71335-0091-9) 40 capsule2019-04-30NoNoCurrent