FDA.reportPublic FDA data

benzonatate

Product NDC
11788-028
11-digit product format
117880028
Labeler code
11788
Product ID
11788-028_eba5c6f6-e360-8022-e053-2995a90a2409
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA210562
Marketing category
ANDA
Marketing start
2019-03-14
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
11788-028-002024-01-30C16284748780-11030e365-2fc0-111a-e063-dadaa90a10e2Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
11788-028-012024-01-30C16284748780-11030e365-6573-111a-e063-dadaa90a10e2Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg
11788-028-052024-01-30C16284748780-11030e365-6573-111a-e063-dadaa90a10e2Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11788-028-00benzonatate44000 in 1 CARTONCAPSULE440003
11788-028-01benzonatate100 in 1 BOTTLECAPSULE1003
11788-028-05benzonatate500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11788-028-01EA - Each11788-028bebddc67-0cbf-4c2e-a2b7-89f51d0bab1912020-01-03
11788-028-05EA - Each11788-02863c43f10-ff43-4d5a-b702-0fa1b7e45f0f12020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11788-028BENZONATATE CAPSULE [AIPING PHARMACEUTICAL, INC.]3Legacy NDC, 2 package rows20221023_b0da7a68-29ff-48aa-a52d-e5b393f6b4f6.zip
11788-028BENZONATATE CAPSULE [AIPING PHARMACEUTICAL, INC.]3Legacy NDC, 1 package rows20200701_7c210c0e-72b8-9656-e053-2991aa0a9455.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN7c210c0e-72b8-9656-e053-2991aa0a94553
197397benzonatate 100 MG Oral CapsulePSNb0da7a68-29ff-48aa-a52d-e5b393f6b4f63
903291benzonatate 150 MG Oral CapsulePSN7c210c0e-72b8-9656-e053-2991aa0a94553
903291benzonatate 150 MG Oral CapsulePSNb0da7a68-29ff-48aa-a52d-e5b393f6b4f63
283417benzonatate 200 MG Oral CapsulePSN7c210c0e-72b8-9656-e053-2991aa0a94553
283417benzonatate 200 MG Oral CapsulePSNb0da7a68-29ff-48aa-a52d-e5b393f6b4f63
197397benzonatate 100 MG Oral CapsuleSCD7c210c0e-72b8-9656-e053-2991aa0a94553
197397benzonatate 100 MG Oral CapsuleSCDb0da7a68-29ff-48aa-a52d-e5b393f6b4f63
903291benzonatate 150 MG Oral CapsuleSCD7c210c0e-72b8-9656-e053-2991aa0a94553
903291benzonatate 150 MG Oral CapsuleSCDb0da7a68-29ff-48aa-a52d-e5b393f6b4f63
283417benzonatate 200 MG Oral CapsuleSCD7c210c0e-72b8-9656-e053-2991aa0a94553
283417benzonatate 200 MG Oral CapsuleSCDb0da7a68-29ff-48aa-a52d-e5b393f6b4f63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11788-028-001178800280044000 CAPSULE in 1 CARTON (11788-028-00) 44000 capsule2019-03-140000-00-00NoNoCurrent
11788-028-0111788002801100 CAPSULE in 1 BOTTLE (11788-028-01) 100 capsule2019-03-140000-00-00NoNoCurrent
11788-028-0511788002805500 CAPSULE in 1 BOTTLE (11788-028-05) 500 capsule2019-03-140000-00-00NoNoCurrent