FDA.reportPublic FDA data

benzonatate

Product NDC
71205-971
11-digit product format
712050971
Labeler code
71205
Product ID
71205-971_492a0004-9824-4df9-ab03-a46953aa4fdb
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, 283417

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
71205-971-00benzonatate100 in 1 BOTTLECAPSULE1002
71205-971-10benzonatate10 in 1 BOTTLECAPSULE102
71205-971-14benzonatate14 in 1 BOTTLECAPSULE142
71205-971-15benzonatate15 in 1 BOTTLECAPSULE152
71205-971-20benzonatate20 in 1 BOTTLECAPSULE202
71205-971-21benzonatate21 in 1 BOTTLECAPSULE212
71205-971-30benzonatate30 in 1 BOTTLECAPSULE302
71205-971-55benzonatate500 in 1 BOTTLECAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-971-00EA - Each71205-971a5c40c47-c3c0-4041-a4a7-ff536c940abb12021-06-02
71205-971-10EA - Each71205-97104036abd-4866-4696-9965-c9437327ccde12021-06-02
71205-971-14EA - Each71205-97164be0a3e-31c3-4cbc-bf67-04464bc99a7d12021-06-02
71205-971-15EA - Each71205-971f3c42686-459a-4b47-a3ef-5108265154c512021-06-02
71205-971-20EA - Each71205-971bf53566e-fcb9-4d83-be05-ef75e280674c12021-06-02
71205-971-21EA - Each71205-97110a13a3c-b0b8-4762-a1de-c165a79448b312021-06-02
71205-971-30EA - Each71205-97135fa088b-3055-466a-8b7b-ce3f6ac10e5812021-06-02
71205-971-55EA - Each71205-97175cba63f-46e9-44cc-9039-890e301a143312021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-971BENZONATATE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 8 package rows20220521_9566b9b9-54ef-423c-8ce4-0f1714052158.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN9566b9b9-54ef-423c-8ce4-0f17140521582
283417benzonatate 200 MG Oral CapsulePSN9566b9b9-54ef-423c-8ce4-0f17140521582
197397benzonatate 100 MG Oral CapsuleSCD9566b9b9-54ef-423c-8ce4-0f17140521582
283417benzonatate 200 MG Oral CapsuleSCD9566b9b9-54ef-423c-8ce4-0f17140521582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-971-0071205097100100 CAPSULE in 1 BOTTLE (71205-971-00) 100 capsule2020-06-040000-00-00NoNoCurrent
71205-971-107120509711010 CAPSULE in 1 BOTTLE (71205-971-10) 10 capsule2020-06-040000-00-00NoNoCurrent
71205-971-147120509711414 CAPSULE in 1 BOTTLE (71205-971-14) 14 capsule2020-06-040000-00-00NoNoCurrent
71205-971-157120509711515 CAPSULE in 1 BOTTLE (71205-971-15) 15 capsule2020-06-040000-00-00NoNoCurrent
71205-971-207120509712020 CAPSULE in 1 BOTTLE (71205-971-20) 20 capsule2020-06-040000-00-00NoNoCurrent
71205-971-217120509712121 CAPSULE in 1 BOTTLE (71205-971-21) 21 capsule2020-06-040000-00-00NoNoCurrent
71205-971-307120509713030 CAPSULE in 1 BOTTLE (71205-971-30) 30 capsule2020-06-040000-00-00NoNoCurrent
71205-971-5571205097155500 CAPSULE in 1 BOTTLE (71205-971-55) 500 capsule2020-06-040000-00-00NoNoCurrent