FDA.reportPublic FDA data

Benzonatate

Product NDC
31722-956
11-digit product format
317220956
Labeler code
31722
Product ID
31722-956_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
100 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
BENZONATATE100 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
31722-956-01Benzonatate100 in 1 BOTTLECAPSULE1004
31722-956-05Benzonatate500 in 1 BOTTLECAPSULE5004
31722-956-30Benzonatate30 in 1 BOTTLECAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-956-01EA - Each31722-956d714b0a9-fe84-40ec-9b82-580bb29e35eb12019-09-05
31722-956-05EA - Each31722-9564ce0dd7f-62c9-439e-a5c7-d79a40fd999b12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-956BENZONATATE 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
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
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
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
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
197397benzonatate 100 MG Oral CapsulePSN45d9b32a-3198-49d5-addf-f077fec50b9c1
197397benzonatate 100 MG Oral CapsulePSN47560d98-f4c4-4738-85fe-41cbed09ed591
197397benzonatate 100 MG Oral CapsuleSCD45d9b32a-3198-49d5-addf-f077fec50b9c1
197397benzonatate 100 MG Oral CapsuleSCD47560d98-f4c4-4738-85fe-41cbed09ed591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-956-0131722095601100 CAPSULE in 1 BOTTLE (31722-956-01) 100 capsule2019-02-220000-00-00NoNoCurrent
31722-956-0531722095605500 CAPSULE in 1 BOTTLE (31722-956-05) 500 capsule2019-02-220000-00-00NoNoCurrent
31722-956-303172209563030 CAPSULE in 1 BOTTLE (31722-956-30) 30 capsule2019-02-220000-00-00NoNoCurrent