FDA.reportPublic FDA data

Benzonatate

Product NDC
71205-853
11-digit product format
712050853
Labeler code
71205
Product ID
71205-853_45d9b32a-3198-49d5-addf-f077fec50b9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA211518
Marketing category
ANDA
Marketing start
2019-02-22
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dc429dc2-e942-6686-8d72-b63c57e806aaProduct name520190416
d45c2ed6-126c-dd22-afd2-e29a2ecf77b9Product name320190215

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-853-00Benzonatate100 in 1 BOTTLECAPSULE1001
71205-853-10Benzonatate10 in 1 BOTTLECAPSULE101
71205-853-14Benzonatate14 in 1 BOTTLECAPSULE141
71205-853-15Benzonatate15 in 1 BOTTLECAPSULE151
71205-853-20Benzonatate20 in 1 BOTTLECAPSULE201
71205-853-21Benzonatate21 in 1 BOTTLECAPSULE211
71205-853-30Benzonatate30 in 1 BOTTLECAPSULE301
71205-853-55Benzonatate500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-853-00EA - Each71205-8530511b3ea-5479-47f9-b649-f49d8a9dfbdf12022-07-06
71205-853-10EA - Each71205-853a0103da2-80a1-41f3-8dd8-50c44080b39012022-07-06
71205-853-14EA - Each71205-853a3c7e439-b87d-4265-8c3a-e0c4553ad9d512022-07-06
71205-853-15EA - Each71205-8535aad91dd-3902-4bfd-8fcf-4631347ff24612022-07-06
71205-853-20EA - Each71205-85304980b44-1264-4e2b-bfbe-1b11e6627a2c12022-07-06
71205-853-21EA - Each71205-85300215210-ed81-4e8a-a739-4485635cc32a12022-07-06
71205-853-30EA - Each71205-85368952491-8b57-4ae7-b0a3-57068b608bcd12022-07-06
71205-853-55EA - Each71205-8538e8885e0-f37a-41c6-baea-7447667a3e8612022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-853BENZONATATE CAPSULE [PROFICIENT RX LP]1Current NDC, Legacy NDC, 8 package rows20220622_45d9b32a-3198-49d5-addf-f077fec50b9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN45d9b32a-3198-49d5-addf-f077fec50b9c1
197397benzonatate 100 MG Oral CapsuleSCD45d9b32a-3198-49d5-addf-f077fec50b9c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-853-0071205085300100 CAPSULE in 1 BOTTLE (71205-853-00) 100 capsule2022-06-200000-00-00NoNoCurrent
71205-853-107120508531010 CAPSULE in 1 BOTTLE (71205-853-10) 10 capsule2022-06-200000-00-00NoNoCurrent
71205-853-147120508531414 CAPSULE in 1 BOTTLE (71205-853-14) 14 capsule2022-06-200000-00-00NoNoCurrent
71205-853-157120508531515 CAPSULE in 1 BOTTLE (71205-853-15) 15 capsule2022-06-200000-00-00NoNoCurrent
71205-853-207120508532020 CAPSULE in 1 BOTTLE (71205-853-20) 20 capsule2022-06-200000-00-00NoNoCurrent
71205-853-217120508532121 CAPSULE in 1 BOTTLE (71205-853-21) 21 capsule2022-06-200000-00-00NoNoCurrent
71205-853-307120508533030 CAPSULE in 1 BOTTLE (71205-853-30) 30 capsule2022-06-200000-00-00NoNoCurrent
71205-853-5571205085355500 CAPSULE in 1 BOTTLE (71205-853-55) 500 capsule2022-06-200000-00-00NoNoCurrent