Home NDC 82982-023 Benzonatate
Product NDC 82982-023
11-digit product format 829820023
Labeler code 82982
Product ID 82982-023_efe6b6f2-c90f-f440-e053-2a95a90a90fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzonatate
Dosage form CAPSULE
Route ORAL
Labeler Pharmasource Meds, LLC
Application ANDA202765
Marketing category ANDA
Marketing start 2023-01-09
Marketing end 0000-00-00
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 2024-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 82982-023-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 82982-023-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 82982-023-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 82982-023-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 82982-023-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 82982-023-30 cdf11ea48f46…ba0047e9e063…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 · 88 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 2026-10-15 13:18:30 2026-09 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 88 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82982-023-30 82982002330 30 CAPSULE in 1 BOTTLE (82982-023-30) 30 capsule 2023-01-09 0000-00-00 No No Current