FDA.reportPublic FDA data

benzonatate

Product NDC
63187-928
11-digit product format
631870928
Labeler code
63187
Product ID
63187-928_5b03582e-fcc5-4cbb-8a72-0c53fcc32900
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040627
Marketing category
ANDA
Marketing start
2017-03-22
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-928-10benzonatate10 in 1 BOTTLECAPSULE103
63187-928-14benzonatate14 in 1 BOTTLECAPSULE143
63187-928-15benzonatate15 in 1 BOTTLECAPSULE153
63187-928-20benzonatate20 in 1 BOTTLECAPSULE203
63187-928-21benzonatate21 in 1 BOTTLECAPSULE213
63187-928-30benzonatate30 in 1 BOTTLECAPSULE303
63187-928-40benzonatate40 in 1 BOTTLECAPSULE403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-928-10EA - Each63187-928b508066e-b5a6-47f2-80cb-f35834c48a2212018-01-12
63187-928-14EA - Each63187-9284bc44759-883d-471f-8147-77dcf11f1f5b12018-11-06
63187-928-20EA - Each63187-928f91f5566-099d-4484-b4f8-6daeb72f8c0b12018-01-12
63187-928-21EA - Each63187-928b230eb11-1954-451a-80f8-221178165f6b12018-11-06
63187-928-30EA - Each63187-928e198ca64-91e2-4de8-aec3-111caa1bfe7612018-02-20
63187-928-40EA - Each63187-92813896e66-00e6-4acd-a2e1-18ae1f92d6af12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-928BENZONATATE CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 7 package rows20200229_9fb78c06-e527-4596-884c-fcf882927a33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN9fb78c06-e527-4596-884c-fcf882927a333
197397benzonatate 100 MG Oral CapsuleSCD9fb78c06-e527-4596-884c-fcf882927a333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-928-106318709281010 CAPSULE in 1 BOTTLE (63187-928-10) 10 capsule2017-11-010000-00-00NoNoCurrent
63187-928-146318709281414 CAPSULE in 1 BOTTLE (63187-928-14) 14 capsule2017-11-010000-00-00NoNoCurrent
63187-928-156318709281515 CAPSULE in 1 BOTTLE (63187-928-15) 15 capsule2017-11-010000-00-00NoNoCurrent
63187-928-206318709282020 CAPSULE in 1 BOTTLE (63187-928-20) 20 capsule2017-11-010000-00-00NoNoCurrent
63187-928-216318709282121 CAPSULE in 1 BOTTLE (63187-928-21) 21 capsule2017-11-010000-00-00NoNoCurrent
63187-928-306318709283030 CAPSULE in 1 BOTTLE (63187-928-30) 30 capsule2017-11-010000-00-00NoNoCurrent
63187-928-406318709284040 CAPSULE in 1 BOTTLE (63187-928-40) 40 capsule2017-11-010000-00-00NoNoCurrent