FDA.reportPublic FDA data

Benzonatate

Product NDC
70518-2491
11-digit product format
705182491
Labeler code
70518
Product ID
70518-2491_51dff223-f709-c42d-e063-6294a90abcc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA206948
Marketing category
ANDA
Marketing start
2019-12-17
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benzonatate
Listing expiration
2027-12-31

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
70518-2491-0Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE3015
70518-2491-1Benzonatate30 in 1 BLISTER PACKCAPSULE3015
70518-2491-2Benzonatate21 in 1 BOTTLE, PLASTICCAPSULE2115
70518-2491-3Benzonatate30 in 1 BOTTLE, PLASTICCAPSULE3015
70518-2491-4Benzonatate21 in 1 BOTTLE, PLASTICCAPSULE2115
70518-2491-5Benzonatate20 in 1 BOTTLE, PLASTICCAPSULE2015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2491BENZONATATE CAPSULE [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 6 package rows20250406_ed756746-4cbb-4196-a972-5a8c23702b2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSNed756746-4cbb-4196-a972-5a8c23702b2a15
283417benzonatate 200 MG Oral CapsuleSCDed756746-4cbb-4196-a972-5a8c23702b2a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2491-07051824910030 CAPSULE in 1 BOTTLE, PLASTIC (70518-2491-0) 30 capsule2019-12-170000-00-00NoNoCurrent
70518-2491-17051824910130 CAPSULE in 1 BLISTER PACK (70518-2491-1) 30 capsule2021-01-260000-00-00NoNoCurrent
70518-2491-27051824910221 CAPSULE in 1 BOTTLE, PLASTIC (70518-2491-2) 21 capsule2022-03-300000-00-00NoNoCurrent
70518-2491-37051824910330 CAPSULE in 1 BOTTLE, PLASTIC (70518-2491-3) 30 capsule2024-10-23NoNoCurrent
70518-2491-47051824910421 CAPSULE in 1 BOTTLE, PLASTIC (70518-2491-4) 21 capsule2025-04-01NoNoCurrent
70518-2491-57051824910520 CAPSULE in 1 BOTTLE, PLASTIC (70518-2491-5) 20 capsule2026-05-13NoNoCurrent