FDA.reportPublic FDA data

Benzonatate

Product NDC
68071-1395
11-digit product format
680711395
Labeler code
68071
Product ID
68071-1395_1d79b80a-e648-7d7d-e063-6294a90a82bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA206948
Marketing category
ANDA
Marketing start
2018-12-21
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1395-32023-12-06C16284748780-1ba0f9c33-47af-a910-e053-dadaa90a0b85Benzonatate Capsules, USP
68071-1395-32023-01-30C16284748780-1ba0f9c33-47af-a910-e053-dadaa90a0b85Benzonatate Capsules, USP
68071-1395-32021-02-10C16284748780-1ba0f9c33-47af-a910-e053-dadaa90a0b85Benzonatate Capsules, USP
68071-1395-32021-01-29C16284748780-1ba0f9c33-47af-a910-e053-dadaa90a0b85Benzonatate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1395-3Benzonatate30 in 1 BOTTLECAPSULE304
68071-1395-5Benzonatate45 in 1 BOTTLECAPSULE454

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1395BENZONATATE CAPSULE [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240719_941afb1f-348b-4340-e053-2995a90ac370.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN941afb1f-348b-4340-e053-2995a90ac3704
283417benzonatate 200 MG Oral CapsuleSCD941afb1f-348b-4340-e053-2995a90ac3704

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1395-36807113950330 CAPSULE in 1 BOTTLE (68071-1395-3) 30 capsule2019-10-040000-00-00NoNoCurrent
68071-1395-56807113950545 CAPSULE in 1 BOTTLE (68071-1395-5) 45 capsule2019-10-04NoNoCurrent