FDA.reportPublic FDA data

Benzonatate

Product NDC
50090-6387
11-digit product format
500906387
Labeler code
50090
Product ID
50090-6387_7cdbe723-81be-453e-b6e2-2f46adc34a11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6387-0Benzonatate20 in 1 BOTTLECAPSULE205
50090-6387-1Benzonatate24 in 1 BOTTLECAPSULE245
50090-6387-2Benzonatate30 in 1 BOTTLECAPSULE305
50090-6387-5Benzonatate15 in 1 BOTTLECAPSULE155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6387-0EA - Each50090-63879673e1eb-e3e4-4099-83e2-7848fa30011b12023-04-07
50090-6387-1EA - Each50090-638727260fea-9b0f-4ac0-90fd-eded9f52437d12023-04-07
50090-6387-2EA - Each50090-6387fefac2e0-e4ea-4b34-bb06-d9d271820bc512023-04-07
50090-6387-5EA - Each50090-638742796ee3-76dc-482c-ba46-cd9fcf62349b12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6387BENZONATATE CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, 4 package rows20231110_1b5364d2-bbd5-4c05-a7b5-a5cdbf1d37e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN1b5364d2-bbd5-4c05-a7b5-a5cdbf1d37e95
197397benzonatate 100 MG Oral CapsuleSCD1b5364d2-bbd5-4c05-a7b5-a5cdbf1d37e95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6387-05009063870020 CAPSULE in 1 BOTTLE (50090-6387-0) 20 capsule2023-03-08NoNoHistorical
50090-6387-15009063870124 CAPSULE in 1 BOTTLE (50090-6387-1) 24 capsule2023-03-08NoNoHistorical
50090-6387-25009063870230 CAPSULE in 1 BOTTLE (50090-6387-2) 30 capsule2023-03-08NoNoHistorical
50090-6387-55009063870515 CAPSULE in 1 BOTTLE (50090-6387-5) 15 capsule2023-03-08NoNoHistorical