FDA.reportPublic FDA data

BENZONATATE

Product NDC
61919-573
11-digit product format
619190573
Labeler code
61919
Product ID
61919-573_e9ade7fe-054a-ef8f-e053-2a95a90a9258
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BENZONATATE
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA040627
Marketing category
ANDA
Marketing start
2019-07-29
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
61919-573-102025-01-30C16284748780-12cef2736-6d80-d83d-e063-dadaa90ab31fBENZONATATE
61919-573-152025-01-30C16284748780-12cef2736-6d80-d83d-e063-dadaa90ab31fBENZONATATE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-573-30BENZONATATE30 in 1 BOTTLECAPSULE305
61919-573-10BENZONATATE10 in 1 BOTTLECAPSULE103
61919-573-15BENZONATATE15 in 1 BOTTLECAPSULE153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-573-15EA - Each61919-57375165d52-ac59-4aad-820b-1aa18931c53212019-08-06
61919-573-20EA - Each61919-573e5861227-238c-4e0f-a358-89dcb24a7c1412019-08-06
61919-573-30EA - Each61919-5737e099dc5-8ec2-4378-bfd5-f7ea7f830be112019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-573BENZONATATE CAPSULE [DIRECT RX]5Legacy NDC, 1 package rows20250221_673bf826-a005-7a38-e053-2991aa0a4cb5.zip
61919-573BENZONATATE CAPSULE [DIRECT_RX]3Legacy NDC, 2 package rows20230509_8ed86bc3-27d0-1d5c-e053-2995a90ae053.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN673bf826-a005-7a38-e053-2991aa0a4cb55
197397benzonatate 100 MG Oral CapsuleSCD673bf826-a005-7a38-e053-2991aa0a4cb55
197397benzonatate 100 MG Oral CapsulePSN8ed86bc3-27d0-1d5c-e053-2995a90ae0533
197397benzonatate 100 MG Oral CapsuleSCD8ed86bc3-27d0-1d5c-e053-2995a90ae0533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-573-106191905731010 CAPSULE in 1 BOTTLE (61919-573-10) 10 capsule2019-07-290000-00-00NoNoCurrent
61919-573-156191905731515 CAPSULE in 1 BOTTLE (61919-573-15) 15 capsule2019-07-290000-00-00NoNoCurrent
61919-573-206191905732020 CAPSULE in 1 BOTTLE (61919-573-20) 20 capsule2019-07-300000-00-00NoNoCurrent
61919-573-306191905733030 CAPSULE in 1 BOTTLE (61919-573-30) 30 capsule2019-04-030000-00-00NoNoCurrent