benzonatate

Product NDC
67877-105
11-digit product format
678770105
Labeler code
67877
Product ID
67877-105_de64cd7e-65b6-4ba2-8ed7-a1c98f2cca4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories LLC
Application
ANDA040627
Marketing category
ANDA
Marketing start
2007-07-25
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-105-01benzonatate100 in 1 BOTTLECAPSULE10013
67877-105-05benzonatate500 in 1 BOTTLECAPSULE50013
67877-105-10benzonatate1000 in 1 BOTTLECAPSULE100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-105-01EA - Each67877-1057ea3d6ae-8e03-40c7-a4d0-cda3258934e612012-07-24
67877-105-05EA - Each67877-1056a0f4aab-38f7-4e2e-9f15-75f1e691dd0612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzonatateACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
benzonatateACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
gelatinINACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
methylparabenINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
waterINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [ASCEND LABORATORIES LLC]11
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]5
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
benzonatateACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [UNIT DOSE SERVICES]4
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
benzonatateACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [UNIT DOSE SERVICES]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [UNIT DOSE SERVICES]4
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [UNIT DOSE SERVICES]4
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [UNIT DOSE SERVICES]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [UNIT DOSE SERVICES]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [UNIT DOSE SERVICES]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [UNIT DOSE SERVICES]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [UNIT DOSE SERVICES]4
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [BLENHEIM PHARMACAL, INC.]4
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]3
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [LIBERTY PHARMACEUTICALS, INC.]3
benzonatateACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
benzonatateACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]2
benzonatateACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
benzonatateACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
waterINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [REDPHARM DRUG INC.]2
waterINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [H.J. HARKINS COMPANY, INC.]2
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
BENZONATATEACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [DIRECT RX]1
benzonatateACTIVE INGREDIENT5P4DHS6ENRBENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]1
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [DIRECT RX]1
BENZONATATEACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
benzonatateACTIVE MOIETY5P4DHS6ENRBENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [DIRECT RX]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [DIRECT RX]1
gelatinINACTIVE INGREDIENT2G86QN327LBENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [DIRECT RX]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [DIRECT RX]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBENZONATATE CAPSULE [DIRECT RX]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENZONATATE CAPSULE [DIRECT RX]1
waterINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [DIRECT RX]1
WATERINACTIVE INGREDIENT059QF0KO0RBENZONATATE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-105BENZONATATE CAPSULE [ASCEND LABORATORIES LLC]13Legacy NDC, 3 package rows20200101_27388883-e698-4501-b8c9-78c76ae9b1e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN27388883-e698-4501-b8c9-78c76ae9b1e113
903291benzonatate 150 MG Oral CapsulePSN27388883-e698-4501-b8c9-78c76ae9b1e113
283417benzonatate 200 MG Oral CapsulePSN27388883-e698-4501-b8c9-78c76ae9b1e113
197397benzonatate 100 MG Oral CapsuleSCD27388883-e698-4501-b8c9-78c76ae9b1e113
903291benzonatate 150 MG Oral CapsuleSCD27388883-e698-4501-b8c9-78c76ae9b1e113
283417benzonatate 200 MG Oral CapsuleSCD27388883-e698-4501-b8c9-78c76ae9b1e113
197397benzonatate 100 MG Oral CapsulePSNb576efe0-83e3-49ca-b84e-434f67d19fc26
197397benzonatate 100 MG Oral CapsuleSCDb576efe0-83e3-49ca-b84e-434f67d19fc26
197397benzonatate 100 MG Oral CapsulePSN11f47c1a-98c1-28eb-e054-00144ff88e885
197397benzonatate 100 MG Oral CapsuleSCD11f47c1a-98c1-28eb-e054-00144ff88e885
197397benzonatate 100 MG Oral CapsulePSN00acfc04-3ad0-487e-87dd-e6e632c05b454
197397benzonatate 100 MG Oral CapsulePSNe2f9df12-891f-43be-90fb-0ca38e72d3df4
283417benzonatate 200 MG Oral CapsulePSN00acfc04-3ad0-487e-87dd-e6e632c05b454
197397benzonatate 100 MG Oral CapsuleSCDe2f9df12-891f-43be-90fb-0ca38e72d3df4
197397benzonatate 100 MG Oral CapsuleSCD00acfc04-3ad0-487e-87dd-e6e632c05b454
283417benzonatate 200 MG Oral CapsuleSCD00acfc04-3ad0-487e-87dd-e6e632c05b454
197397benzonatate 100 MG Oral CapsulePSN057214bd-9892-4e4f-bd93-4c123c30c8ba3
197397benzonatate 100 MG Oral CapsuleSCD057214bd-9892-4e4f-bd93-4c123c30c8ba3
197397benzonatate 100 MG Oral CapsulePSN18e689cf-f504-464f-88d6-cc89aa05a6fc2
197397benzonatate 100 MG Oral CapsulePSNa8861d0d-3ca8-4b46-adc5-5dd322142b962
283417benzonatate 200 MG Oral CapsulePSN18e689cf-f504-464f-88d6-cc89aa05a6fc2
197397benzonatate 100 MG Oral CapsuleSCDa8861d0d-3ca8-4b46-adc5-5dd322142b962
197397benzonatate 100 MG Oral CapsuleSCD18e689cf-f504-464f-88d6-cc89aa05a6fc2
283417benzonatate 200 MG Oral CapsuleSCD18e689cf-f504-464f-88d6-cc89aa05a6fc2
197397benzonatate 100 MG Oral CapsulePSN3c92ce07-da4e-47f0-ba1a-84f6a758bf171
197397benzonatate 100 MG Oral CapsulePSN15dd2f41-952b-40d2-a9bb-5e1cb8802e5e1
283417benzonatate 200 MG Oral CapsulePSN15dd2f41-952b-40d2-a9bb-5e1cb8802e5e1
283417benzonatate 200 MG Oral CapsulePSN3c92ce07-da4e-47f0-ba1a-84f6a758bf171
197397benzonatate 100 MG Oral CapsuleSCD3c92ce07-da4e-47f0-ba1a-84f6a758bf171
197397benzonatate 100 MG Oral CapsuleSCD15dd2f41-952b-40d2-a9bb-5e1cb8802e5e1
283417benzonatate 200 MG Oral CapsuleSCD3c92ce07-da4e-47f0-ba1a-84f6a758bf171
283417benzonatate 200 MG Oral CapsuleSCD15dd2f41-952b-40d2-a9bb-5e1cb8802e5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-105-0167877010501100 CAPSULE in 1 BOTTLE (67877-105-01) 100 capsule2007-07-250000-00-00NoNoCurrent
67877-105-0567877010505500 CAPSULE in 1 BOTTLE (67877-105-05) 500 capsule2007-07-250000-00-00NoNoCurrent
67877-105-10678770105101000 CAPSULE in 1 BOTTLE (67877-105-10) 1000 capsule2007-07-250000-00-00NoNoCurrent