FDA.reportPublic FDA data

Benzonatate

Product NDC
67046-1484
Requested package NDC
67046-1484-3
11-digit product format
670461484
Labeler code
67046
Product ID
67046-1484_2ce03083-d6c3-8a00-e063-6294a90aba68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzonatate
Dosage form
CAPSULE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA081297
Marketing category
ANDA
Marketing start
2025-01-29
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A081297-001BENZONATATEBENZONATATE100MGCAPSULE / ORALAA1993-01-29
A081297-002BENZONATATEBENZONATATE200MGCAPSULE / ORALAA2007-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A081297-001AA
A081297-002AA

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
2026-08-01 22:54:322026-06A081297-001BENZONATATE100MGCAPSULE / ORALAA1993-01-29a50c72e98297…
2026-08-01 22:54:322026-06A081297-002BENZONATATE200MGCAPSULE / ORALAA2007-10-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A081297-001AA1a50c72e98297…
2026-08-01 22:54:322026-06A081297-002AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzonatateBENZONATATEBryant Ranch Prepack5728b147-33a0-4534-b936-3e02274d94672026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATEGolden State Medical Supply, Inc.d580b1c9-d450-4032-acb2-0563c589ed2c2026-07-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATEBionpharma Inc.2630be01-1d2d-4c40-8e56-8568ea89eacf2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATEBryant Ranch Prepack540d2bc6-11dc-43d7-b616-b89d75b81cd12026-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATECoupler LLC2ce035ff-42cb-d8ef-e063-6294a90a0c062025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
ndc (package): 67046-1484-3
ndc (product): 67046-1484
ndc11 (package): 67046148403
BenzonatateBENZONATATENuCare Pharmaceuticals,Inc.9cab4544-e0ab-3fdd-e053-2995a90ad0492024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATENuCare Pharmaceuticals,Inc.96b260c3-e177-73c3-e053-2a95a90a775e2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATEAphena Pharma Solutions - Tennessee, LLC3bd33aec-9a30-4581-bd28-6cfb67772cef2023-03-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATEProficient Rx LPbc435603-ddc4-4083-af09-2e562defbe7f2022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297
BenzonatateBENZONATATEProficient Rx LP0d14cbf4-f43f-4ad2-8e8b-7a844e4177022020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 081297
application number: ANDA081297

Additional Listing Data#

Finished product
Yes
Brand name base
Benzonatate
Listing expiration
2026-12-31

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ce035ff-42cb-d8ef-e063-6294a90a0c06Available 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
67046-1484-3Benzonatate30 in 1 BLISTER PACKCAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1484BENZONATATE CAPSULE [COUPLER LLC]1Current NDC, 1 package rows20250130_2ce035ff-42cb-d8ef-e063-6294a90a0c06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197397benzonatate 100 MG Oral CapsulePSN2ce035ff-42cb-d8ef-e063-6294a90a0c061
197397benzonatate 100 MG Oral CapsuleSCD2ce035ff-42cb-d8ef-e063-6294a90a0c061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1484-36704614840330 CAPSULE in 1 BLISTER PACK (67046-1484-3) 30 capsule2025-01-29NoNoCurrent