FDA.reportPublic FDA data

Benzonatate

Product NDC
72789-230
11-digit product format
727890230
Labeler code
72789
Product ID
72789-230_2d6c8457-a91d-08a1-e063-6294a90a2807
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA206948
Marketing category
ANDA
Marketing start
2018-12-21
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
72789-230-06Benzonatate6 in 1 BOTTLE, PLASTICCAPSULE69
72789-230-12Benzonatate12 in 1 BOTTLE, PLASTICCAPSULE129
72789-230-15Benzonatate15 in 1 BOTTLE, PLASTICCAPSULE159
72789-230-20Benzonatate20 in 1 BOTTLE, PLASTICCAPSULE209
72789-230-21Benzonatate21 in 1 BOTTLE, PLASTICCAPSULE219
72789-230-30Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-230-06EA - Each72789-23081273974-b02e-4f5b-b1cd-9ac96b6d809b12022-10-06
72789-230-12EA - Each72789-23057fd21ae-bbc1-4cc7-85d7-17eb3018c32712022-10-06
72789-230-15EA - Each72789-230b6e8c30d-d473-4422-a1e6-08933da1958812022-10-06
72789-230-20EA - Each72789-230431e9256-851a-4b1f-b1e0-b909c5f95b0712022-10-06
72789-230-21EA - Each72789-2305d99c45f-9ad2-4bd5-bdbf-82fa4bdbf0a212022-10-06
72789-230-30EA - Each72789-2302832e1aa-b616-4116-b244-ca1804137f7612022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-230BENZONATATE CAPSULE [PD-RX PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 6 package rows20250207_70e157f2-1670-422c-a70d-f9576e1647ea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN70e157f2-1670-422c-a70d-f9576e1647ea9
197397benzonatate 100 MG Oral CapsuleSCD70e157f2-1670-422c-a70d-f9576e1647ea9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-230-06727890230066 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-06) 6 capsule2022-08-160000-00-00NoNoCurrent
72789-230-127278902301212 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-12) 12 capsule2022-07-210000-00-00NoNoCurrent
72789-230-157278902301515 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-15) 15 capsule2022-02-020000-00-00NoNoCurrent
72789-230-207278902302020 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-20) 20 capsule2022-02-160000-00-00NoNoCurrent
72789-230-217278902302121 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-21) 21 capsule2022-02-020000-00-00NoNoCurrent
72789-230-307278902303030 CAPSULE in 1 BOTTLE, PLASTIC (72789-230-30) 30 capsule2022-02-020000-00-00NoNoCurrent