FDA.reportPublic FDA data

Benzonatate

Product NDC
68382-091
11-digit product format
683820091
Labeler code
68382
Product ID
68382-091_52dc3ff3-f01b-4820-ba1e-b043a5b2c49a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-091-01Benzonatate100 in 1 BOTTLECAPSULE10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-091-01EA - Each68382-091d230b1a7-bb8f-41af-9cf2-6eb4d1d0d84812021-10-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-091BENZONATATE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 1 package rows20230917_331c70dc-005e-4d96-a35c-4d2d810aa3b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN331c70dc-005e-4d96-a35c-4d2d810aa3b110
283417benzonatate 200 MG Oral CapsulePSN331c70dc-005e-4d96-a35c-4d2d810aa3b110
197397benzonatate 100 MG Oral CapsuleSCD331c70dc-005e-4d96-a35c-4d2d810aa3b110
283417benzonatate 200 MG Oral CapsuleSCD331c70dc-005e-4d96-a35c-4d2d810aa3b110
283417benzonatate 200 MG Oral CapsulePSN32524a8a-4cee-26c0-e063-6294a90aa8985
283417benzonatate 200 MG Oral CapsuleSCD32524a8a-4cee-26c0-e063-6294a90aa8985
283417benzonatate 200 MG Oral CapsulePSN6f7f4a31-99ec-45ca-84d7-0be3640d1e0b4
283417benzonatate 200 MG Oral CapsuleSCD6f7f4a31-99ec-45ca-84d7-0be3640d1e0b4
283417benzonatate 200 MG Oral CapsulePSN995ebc53-4e13-4c1d-b301-71ac83c6def81
283417benzonatate 200 MG Oral CapsulePSNb3b16ea5-4572-470e-8124-fc38b1d49e3e1
283417benzonatate 200 MG Oral CapsuleSCD995ebc53-4e13-4c1d-b301-71ac83c6def81
283417benzonatate 200 MG Oral CapsuleSCDb3b16ea5-4572-470e-8124-fc38b1d49e3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-091-0168382009101100 CAPSULE in 1 BOTTLE (68382-091-01) 100 capsule2007-04-090000-00-00NoNoCurrent