FDA.reportPublic FDA data

Benzonatate

Product NDC
71205-605
11-digit product format
712050605
Labeler code
71205
Product ID
71205-605_2fae3438-3fe9-4f4f-bd89-35fb7050c560
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA081297
Marketing category
ANDA
Marketing start
2016-08-15
Substance
BENZONATATE
Active strength
200 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
BENZONATATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5P4DHS6ENR
Rxcui283417

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
71205-605-10Benzonatate10 in 1 BOTTLE, PLASTICCAPSULE102
71205-605-14Benzonatate14 in 1 BOTTLE, PLASTICCAPSULE142
71205-605-15Benzonatate15 in 1 BOTTLE, PLASTICCAPSULE152
71205-605-20Benzonatate20 in 1 BOTTLE, PLASTICCAPSULE202
71205-605-21Benzonatate21 in 1 BOTTLE, PLASTICCAPSULE212
71205-605-30Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE302
71205-605-40Benzonatate40 in 1 BOTTLE, PLASTICCAPSULE402
71205-605-60Benzonatate60 in 1 BOTTLE, PLASTICCAPSULE602
71205-605-90Benzonatate90 in 1 BOTTLE, PLASTICCAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-605-14EA - Each71205-605646efba3-05d4-4036-8ce0-e7c8125c85f012022-02-07
71205-605-20EA - Each71205-60568f4f04d-2f3d-430f-8dbc-7b2fc73a0d5812022-02-07
71205-605-21EA - Each71205-60525c1ec1d-88b7-4009-88d2-3043c627c0c812022-02-07
71205-605-30EA - Each71205-60572acf409-423c-4090-ab1e-5298626d0c1112022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-605BENZONATATE CAPSULE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 9 package rows20220514_bc435603-ddc4-4083-af09-2e562defbe7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSNbc435603-ddc4-4083-af09-2e562defbe7f2
283417benzonatate 200 MG Oral CapsuleSCDbc435603-ddc4-4083-af09-2e562defbe7f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-605-107120506051010 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-10) 10 capsule2021-09-150000-00-00NoNoCurrent
71205-605-147120506051414 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-14) 14 capsule2021-09-150000-00-00NoNoCurrent
71205-605-157120506051515 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-15) 15 capsule2021-09-150000-00-00NoNoCurrent
71205-605-207120506052020 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-20) 20 capsule2021-09-150000-00-00NoNoCurrent
71205-605-217120506052121 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-21) 21 capsule2021-09-150000-00-00NoNoCurrent
71205-605-307120506053030 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-30) 30 capsule2021-09-150000-00-00NoNoCurrent
71205-605-407120506054040 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-40) 40 capsule2021-09-150000-00-00NoNoCurrent
71205-605-607120506056060 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-60) 60 capsule2021-09-150000-00-00NoNoCurrent
71205-605-907120506059090 CAPSULE in 1 BOTTLE, PLASTIC (71205-605-90) 90 capsule2021-09-150000-00-00NoNoCurrent