FDA.reportPublic FDA data

Benzonatate

Product NDC
12634-826
11-digit product format
126340826
Labeler code
12634
Product ID
12634-826_271eab2b-ed12-39f1-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA040682
Marketing category
ANDA
Marketing start
2010-06-04
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
2019-12-31
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
12634-826-012020-01-31C16284748780-19d75b9d1-02df-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg and 200 mg
12634-826-542020-01-31C16284748780-19d75b9d1-02df-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg and 200 mg
12634-826-612020-01-31C16284748780-19d75b9d1-02df-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg and 200 mg
12634-826-712020-01-31C16284748780-19d75b9d1-02df-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg and 200 mg
12634-826-802020-01-31C16284748780-19d75b9d1-02df-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg and 200 mg
12634-826-822020-01-31C16284748780-19d75b9d1-02df-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg and 200 mg
12634-826-852020-01-31C16284748780-19d75b9d1-02df-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg and 200 mg
12634-826-882020-01-31C16284748780-19d75b9d1-02df-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg and 200 mg
12634-826-912020-01-31C16284748780-19d75b9d1-02df-f424-e053-dadaa90a57ceBenzonatate Capsules, USP 100 mg and 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-826-01Benzonatate100 in 1 BOTTLECAPSULE, LIQUID FILLED1001
12634-826-54Benzonatate14 in 1 BLISTER PACKCAPSULE, LIQUID FILLED141
12634-826-61Benzonatate10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED101
12634-826-71Benzonatate30 in 1 BOTTLECAPSULE, LIQUID FILLED301
12634-826-80Benzonatate20 in 1 BOTTLECAPSULE, LIQUID FILLED201
12634-826-82Benzonatate12 in 1 BOTTLECAPSULE, LIQUID FILLED121
12634-826-85Benzonatate15 in 1 BOTTLECAPSULE, LIQUID FILLED151
12634-826-88Benzonatate18 in 1 BOTTLECAPSULE, LIQUID FILLED181
12634-826-91Benzonatate1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-826BENZONATATE CAPSULE, LIQUID FILLED [APOTHECA INC.]1Legacy NDC, 9 package rows20151218_271eabf9-0568-3974-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN271eabf9-0568-3974-e054-00144ff88e881
197397benzonatate 100 MG Oral CapsuleSCD271eabf9-0568-3974-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-826-0112634082601100 in 1 BOTTLEHistorical
12634-826-541263408265414 in 1 BLISTER PACKHistorical
12634-826-611263408266110 in 1 BLISTER PACKHistorical
12634-826-711263408267130 in 1 BOTTLEHistorical
12634-826-801263408268020 in 1 BOTTLEHistorical
12634-826-821263408268212 in 1 BOTTLEHistorical
12634-826-851263408268515 in 1 BOTTLEHistorical
12634-826-881263408268818 in 1 BOTTLEHistorical
12634-826-91126340826911 in 1 BLISTER PACKHistorical