FDA.reportPublic FDA data

Benzonatate

Product NDC
64380-713
11-digit product format
643800713
Labeler code
64380
Product ID
64380-713_21343425-d42f-4a46-ba47-30cedc9fe876
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA091133
Marketing category
ANDA
Marketing start
2016-12-10
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
Rxcui197397, 283417

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
64380-713-062022-09-08C16284748780-1e4f33bdf-a62e-d8a0-e053-dadaa90a6e4eBenzonatate Capsules, USP
64380-713-072022-09-08C16284748780-1e4f33bdf-a62e-d8a0-e053-dadaa90a6e4eBenzonatate Capsules, USP
64380-713-062022-07-29C16284748780-1e4f33bdf-a62e-d8a0-e053-dadaa90a6e4eBenzonatate Capsules, USP
64380-713-072022-07-29C16284748780-1e4f33bdf-a62e-d8a0-e053-dadaa90a6e4eBenzonatate Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-713-06Benzonatate100 in 1 CONTAINERCAPSULE1009
64380-713-07Benzonatate500 in 1 BOTTLECAPSULE5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-713-06EA - Each64380-71382c60efa-0df0-4577-a842-f34efa0015b612015-09-10
64380-713-07EA - Each64380-713095fbc38-7e17-4091-aca0-59b1de43b8bc12016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]2
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]2
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [STRIDES ARCOLAB LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-713BENZONATATE CAPSULE [STRIDES PHARMA SCIENCE LIMITED]9Current NDC, Legacy NDC, 2 package rows20250311_89f5d18e-5ef4-42a3-bc6f-abf4f308462b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN89f5d18e-5ef4-42a3-bc6f-abf4f308462b9
283417benzonatate 200 MG Oral CapsulePSN89f5d18e-5ef4-42a3-bc6f-abf4f308462b9
197397benzonatate 100 MG Oral CapsuleSCD89f5d18e-5ef4-42a3-bc6f-abf4f308462b9
283417benzonatate 200 MG Oral CapsuleSCD89f5d18e-5ef4-42a3-bc6f-abf4f308462b9
283417benzonatate 200 MG Oral CapsulePSNf3c2acfc-f598-50ab-e053-2a95a90a11e73
283417benzonatate 200 MG Oral CapsuleSCDf3c2acfc-f598-50ab-e053-2a95a90a11e73
197397benzonatate 100 MG Oral CapsulePSN0b50405c-d399-edcd-e063-6294a90a89c22
283417benzonatate 200 MG Oral CapsulePSN0b50405c-d399-edcd-e063-6294a90a89c22
197397benzonatate 100 MG Oral CapsuleSCD0b50405c-d399-edcd-e063-6294a90a89c22
283417benzonatate 200 MG Oral CapsuleSCD0b50405c-d399-edcd-e063-6294a90a89c22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-713-0664380071306100 CAPSULE in 1 CONTAINER (64380-713-06) 100 capsule2016-12-100000-00-00NoNoCurrent
64380-713-0764380071307500 CAPSULE in 1 BOTTLE (64380-713-07) 500 capsule2016-12-160000-00-00NoNoCurrent