FDA.reportPublic FDA data

Benzonatate

Product NDC
68382-247
11-digit product format
683820247
Labeler code
68382
Product ID
68382-247_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
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, 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
68382-247-01Benzonatate100 in 1 BOTTLECAPSULE10010
68382-247-05Benzonatate500 in 1 BOTTLECAPSULE50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-247-01EA - Each68382-247a6464af9-b4dc-4273-beb0-80c01b6c787e12012-07-24
68382-247-05EA - Each68382-247c65240ba-5baf-4895-960b-bc52bb1a233912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE ( BENZONATATE ) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE ( BENZONATATE ) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE ( BENZONATATE ) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE ( BENZONATATE ) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE ( BENZONATATE ) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE ( BENZONATATE ) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
SORBITOLINACTIVE INGREDIENT506T60A25RBENZONATATE ( BENZONATATE ) CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RBENZONATATE ( BENZONATATE ) CAPSULE [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [AMERICAN HEALTH PACKAGING]2
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE ( BENZONATATE ) CAPSULE [PHYSICIANS TOTAL CARE, 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
68382-247BENZONATATE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20230917_331c70dc-005e-4d96-a35c-4d2d810aa3b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN2256f7e4-b7e6-433f-941e-bf78ddcd55b210
197397benzonatate 100 MG Oral CapsulePSN331c70dc-005e-4d96-a35c-4d2d810aa3b110
283417benzonatate 200 MG Oral CapsulePSN331c70dc-005e-4d96-a35c-4d2d810aa3b110
197397benzonatate 100 MG Oral CapsuleSCD2256f7e4-b7e6-433f-941e-bf78ddcd55b210
197397benzonatate 100 MG Oral CapsuleSCD331c70dc-005e-4d96-a35c-4d2d810aa3b110
283417benzonatate 200 MG Oral CapsuleSCD331c70dc-005e-4d96-a35c-4d2d810aa3b110
197397benzonatate 100 MG Oral CapsulePSN1b5364d2-bbd5-4c05-a7b5-a5cdbf1d37e95
197397benzonatate 100 MG Oral CapsulePSN59900776-1820-3f2a-e053-2a91aa0aa9e35
197397benzonatate 100 MG Oral CapsulePSN673bf826-a005-7a38-e053-2991aa0a4cb55
197397benzonatate 100 MG Oral CapsulePSN9a71725a-64b6-4800-a79c-aa4b2d74d44f5
197397benzonatate 100 MG Oral CapsulePSN751d9d60-cd6b-4aa1-b68f-61b86c4059ad5
197397benzonatate 100 MG Oral CapsuleSCD751d9d60-cd6b-4aa1-b68f-61b86c4059ad5
197397benzonatate 100 MG Oral CapsuleSCD9a71725a-64b6-4800-a79c-aa4b2d74d44f5
197397benzonatate 100 MG Oral CapsuleSCD1b5364d2-bbd5-4c05-a7b5-a5cdbf1d37e95
197397benzonatate 100 MG Oral CapsuleSCD673bf826-a005-7a38-e053-2991aa0a4cb55
197397benzonatate 100 MG Oral CapsuleSCD59900776-1820-3f2a-e053-2a91aa0aa9e35
197397benzonatate 100 MG Oral CapsulePSNa7b12862-1c9f-4712-93e6-a859b24728c23
197397benzonatate 100 MG Oral CapsuleSCDa7b12862-1c9f-4712-93e6-a859b24728c23
197397benzonatate 100 MG Oral CapsulePSNe0f1b5cf-863c-42fa-acd9-43a7e30b40542
283417benzonatate 200 MG Oral CapsulePSNe0f1b5cf-863c-42fa-acd9-43a7e30b40542
197397benzonatate 100 MG Oral CapsuleSCDe0f1b5cf-863c-42fa-acd9-43a7e30b40542
283417benzonatate 200 MG Oral CapsuleSCDe0f1b5cf-863c-42fa-acd9-43a7e30b40542
197397benzonatate 100 MG Oral CapsulePSNb87a7e18-bb47-4b25-be9e-6200fb73b4b41
197397benzonatate 100 MG Oral CapsuleSCDb87a7e18-bb47-4b25-be9e-6200fb73b4b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-247-0168382024701100 CAPSULE in 1 BOTTLE (68382-247-01) 100 capsule2007-04-090000-00-00NoNoCurrent
68382-247-0568382024705500 CAPSULE in 1 BOTTLE (68382-247-05) 500 capsule2007-04-090000-00-00NoNoCurrent