FDA.reportPublic FDA data

Benzonatate

Product NDC
31722-958
11-digit product format
317220958
Labeler code
31722
Product ID
31722-958_96072246-c7e6-4180-8ed4-db7779be5635
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA211518
Marketing category
ANDA
Marketing start
2019-02-22
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
Rxcui197397, 283417, 903291

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
31722-958-01Benzonatate100 in 1 BOTTLECAPSULE1004
31722-958-05Benzonatate500 in 1 BOTTLECAPSULE5004
31722-958-30Benzonatate30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-958-01EA - Each31722-958ea3b23a8-afd7-441e-ba43-d4067a21be7912019-09-05
31722-958-05EA - Each31722-95867fc1c76-a90e-448b-8088-021ee8ce845612019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-958BENZONATATE CAPSULE [CAMBER PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 3 package rows20210729_c21afd18-3b04-4f15-874b-25e0c768f801.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283417benzonatate 200 MG Oral CapsulePSN0f91fd98-1a86-42aa-8055-d339bff73015104
283417benzonatate 200 MG Oral CapsuleSCD0f91fd98-1a86-42aa-8055-d339bff73015104
283417benzonatate 200 MG Oral CapsulePSNda093b5e-83a7-467e-9716-bc5827a18c20100
283417benzonatate 200 MG Oral CapsulePSN865a6317-c697-4dbe-9074-4a955036cdd7100
283417benzonatate 200 MG Oral CapsuleSCDda093b5e-83a7-467e-9716-bc5827a18c20100
283417benzonatate 200 MG Oral CapsuleSCD865a6317-c697-4dbe-9074-4a955036cdd7100
283417benzonatate 200 MG Oral CapsulePSNcfd54d90-c15d-0d02-e053-2995a90a8b285
283417benzonatate 200 MG Oral CapsulePSN3268cde5-65ae-43d2-95c6-b8bb4c32a6fd5
283417benzonatate 200 MG Oral CapsulePSN9815f3f4-fb46-4796-a0ed-62a9e098286d5
283417benzonatate 200 MG Oral CapsuleSCDcfd54d90-c15d-0d02-e053-2995a90a8b285
283417benzonatate 200 MG Oral CapsuleSCD9815f3f4-fb46-4796-a0ed-62a9e098286d5
283417benzonatate 200 MG Oral CapsuleSCD3268cde5-65ae-43d2-95c6-b8bb4c32a6fd5
197397benzonatate 100 MG Oral CapsulePSNc21afd18-3b04-4f15-874b-25e0c768f8014
903291benzonatate 150 MG Oral CapsulePSNc21afd18-3b04-4f15-874b-25e0c768f8014
283417benzonatate 200 MG Oral CapsulePSNc21afd18-3b04-4f15-874b-25e0c768f8014
283417benzonatate 200 MG Oral CapsulePSNfe5e8a94-ac75-4657-a45a-1fe94dbe0d434
197397benzonatate 100 MG Oral CapsuleSCDc21afd18-3b04-4f15-874b-25e0c768f8014
903291benzonatate 150 MG Oral CapsuleSCDc21afd18-3b04-4f15-874b-25e0c768f8014
283417benzonatate 200 MG Oral CapsuleSCDc21afd18-3b04-4f15-874b-25e0c768f8014
283417benzonatate 200 MG Oral CapsuleSCDfe5e8a94-ac75-4657-a45a-1fe94dbe0d434
283417benzonatate 200 MG Oral CapsulePSN2b4b22e9-a03d-fb8f-e063-6394a90a87473
283417benzonatate 200 MG Oral CapsulePSNf3c23663-0cb7-ffa4-e053-2a95a90a9ae03
283417benzonatate 200 MG Oral CapsuleSCD2b4b22e9-a03d-fb8f-e063-6394a90a87473
283417benzonatate 200 MG Oral CapsuleSCDf3c23663-0cb7-ffa4-e053-2a95a90a9ae03
197397benzonatate 100 MG Oral CapsulePSNdf48d617-a3c2-4776-937d-ccfca651d4fc2
903291benzonatate 150 MG Oral CapsulePSNdf48d617-a3c2-4776-937d-ccfca651d4fc2
283417benzonatate 200 MG Oral CapsulePSNdf48d617-a3c2-4776-937d-ccfca651d4fc2
283417benzonatate 200 MG Oral CapsulePSNf4337699-3279-4c08-94f4-caba6d866f632
197397benzonatate 100 MG Oral CapsuleSCDdf48d617-a3c2-4776-937d-ccfca651d4fc2
903291benzonatate 150 MG Oral CapsuleSCDdf48d617-a3c2-4776-937d-ccfca651d4fc2
283417benzonatate 200 MG Oral CapsuleSCDdf48d617-a3c2-4776-937d-ccfca651d4fc2
283417benzonatate 200 MG Oral CapsuleSCDf4337699-3279-4c08-94f4-caba6d866f632
283417benzonatate 200 MG Oral CapsulePSN8dcaeabf-e7da-4e0c-b6db-0bd425d6506e1
283417benzonatate 200 MG Oral CapsulePSNda8fcba7-a43e-4463-96ac-104c7613d64f1
283417benzonatate 200 MG Oral CapsuleSCDda8fcba7-a43e-4463-96ac-104c7613d64f1
283417benzonatate 200 MG Oral CapsuleSCD8dcaeabf-e7da-4e0c-b6db-0bd425d6506e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-958-0131722095801100 CAPSULE in 1 BOTTLE (31722-958-01) 100 capsule2019-02-220000-00-00NoNoCurrent
31722-958-0531722095805500 CAPSULE in 1 BOTTLE (31722-958-05) 500 capsule2019-02-220000-00-00NoNoCurrent
31722-958-303172209583030 CAPSULE in 1 BOTTLE (31722-958-30) 30 capsule2019-02-220000-00-00NoNoCurrent