FDA.reportPublic FDA data

Benzonatate

Product NDC
63187-799
11-digit product format
631870799
Labeler code
63187
Product ID
63187-799_f4c90607-02fd-4956-809c-6045cb48720c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040597
Marketing category
ANDA
Marketing start
2007-04-09
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
63187-799-14Benzonatate14 in 1 BOTTLECAPSULE143
63187-799-15Benzonatate15 in 1 BOTTLECAPSULE153
63187-799-20Benzonatate20 in 1 BOTTLECAPSULE203
63187-799-30Benzonatate30 in 1 BOTTLECAPSULE303
63187-799-40Benzonatate40 in 1 BOTTLECAPSULE403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-799-40EA - Each63187-7993f2d0a96-53fb-41c7-9782-eaea79e7fc5c12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-799BENZONATATE CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 5 package rows20191115_a7b12862-1c9f-4712-93e6-a859b24728c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSNa7b12862-1c9f-4712-93e6-a859b24728c23
197397benzonatate 100 MG Oral CapsuleSCDa7b12862-1c9f-4712-93e6-a859b24728c23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-799-146318707991414 CAPSULE in 1 BOTTLE (63187-799-14) 14 capsule2016-12-010000-00-00NoNoCurrent
63187-799-156318707991515 CAPSULE in 1 BOTTLE (63187-799-15) 15 capsule2016-12-010000-00-00NoNoCurrent
63187-799-206318707992020 CAPSULE in 1 BOTTLE (63187-799-20) 20 capsule2016-12-010000-00-00NoNoCurrent
63187-799-306318707993030 CAPSULE in 1 BOTTLE (63187-799-30) 30 capsule2016-12-010000-00-00NoNoCurrent
63187-799-406318707994040 CAPSULE in 1 BOTTLE (63187-799-40) 40 capsule2016-12-010000-00-00NoNoCurrent