FDA.reportPublic FDA data

Benzonatate 100 mg

Product NDC
25000-002
11-digit product format
250000002
Labeler code
25000
Product ID
25000-002_8668f10d-45dc-4248-88ac-6e8c5d576435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate 100 mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA220298
Marketing category
ANDA
Marketing start
2026-04-10
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220298-001BENZONATATEBENZONATATE100MGCAPSULE / ORALAA2026-03-30
A220298-002BENZONATATEBENZONATATE200MGCAPSULE / ORALAA2026-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A220298-001AA
A220298-002AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A220298-001BENZONATATE100MGCAPSULE / ORALAA2026-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A220298-002BENZONATATE200MGCAPSULE / ORALAA2026-03-30caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220298-001BENZONATATE100MGCAPSULE / ORALAA2026-03-30a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220298-002BENZONATATE200MGCAPSULE / ORALAA2026-03-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A220298-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07A220298-002AA1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220298-001AA1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220298-002AA1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Benzonatate 100 mg
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZONATATE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5P4DHS6ENRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197397Internal RxNorm lookup
283417Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
44104cfc-df60-4d48-9fe1-53456a5e1974Available on FDA.report

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
25000-002-03Benzonatate 100 mg30 in 1 BOTTLECAPSULE, LIQUID FILLED304
25000-002-08Benzonatate 100 mg100 in 1 BOTTLECAPSULE, LIQUID FILLED1004
25000-002-12Benzonatate 100 mg500 in 1 BOTTLECAPSULE, LIQUID FILLED5004

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzonatate 100 mgBENZONATATE 100 MGMARKSANS PHARMA LIMITED44104cfc-df60-4d48-9fe1-53456a5e19742026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220298
application number: ANDA220298
ndc (product): 25000-002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN44104cfc-df60-4d48-9fe1-53456a5e19744
283417benzonatate 200 MG Oral CapsulePSN44104cfc-df60-4d48-9fe1-53456a5e19744
197397benzonatate 100 MG Oral CapsuleSCD44104cfc-df60-4d48-9fe1-53456a5e19744
283417benzonatate 200 MG Oral CapsuleSCD44104cfc-df60-4d48-9fe1-53456a5e19744

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
25000-002-032500000020330 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-002-03) 2026-04-10NoNoCurrent
25000-002-0825000000208100 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-002-08) 2026-04-10NoNoCurrent
25000-002-1225000000212500 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-002-12) 2026-04-10NoNoCurrent