Home NDC 68094-798 Benzonatate
Product NDC 68094-798
11-digit product format 680940798
Labeler code 68094
Product ID 68094-798_02b6bfad-6cc9-4e9e-9320-3ba093f5ae8b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzonatate
Dosage form CAPSULE
Route ORAL
Labeler Precision Dose, Inc.
Application ANDA202765
Marketing category ANDA
Marketing start 2024-03-01
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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202765-001 BENZONATATE BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 A202765-002 BENZONATATE BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Benzonatate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZONATATE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5P4DHS6ENR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197397 Internal RxNorm lookup 283417 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68094-798-50 Benzonatate 100 in 1 BOTTLE CAPSULE 100 1 68094-798-60 Benzonatate 500 in 1 BOTTLE CAPSULE 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68094-798 BENZONATATE CAPSULE [PRECISION DOSE, INC.] 1 Current NDC, 2 package rows 20240301_978d0c83-bc01-49b2-a08a-61d72ee58ff8.zip
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 2 of 2 · 21 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68094-798-50 68094079850 100 CAPSULE in 1 BOTTLE (68094-798-50) 100 capsule 2024-03-01 No No Current 68094-798-60 68094079860 500 CAPSULE in 1 BOTTLE (68094-798-60) 500 capsule 2024-03-01 No No Current