Home NDC 0440-5187 benzonatate
Product NDC 0440-5187
11-digit product format 004405187
Labeler code 0440
Product ID 0440-5187_21751aed-a74f-46b7-bd18-d43c5cc40d86
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benzonatate
Dosage form CAPSULE
Route ORAL
Labeler Liberty Pharmaceuticals, Inc.
Application ANDA201209
Marketing category ANDA
Marketing start 2017-03-22
Marketing end 0000-00-00
Substance BENZONATATE
Active strength 150 mg/1
Pharmacologic classes Decreased Tracheobronchial Stretch Receptor Activity [PE],Non-narcotic Antitussive [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 24 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 0440-5187-01 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 0440-5187-01 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 0440-5187-01 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 0440-5187-01 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 0440-5187-01 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 0440-5187-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0440-5187-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0440-5187-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0440-5187-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0440-5187-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0440-5187-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0440-5187-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog .
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2019-12-13 00:20 UTC 2019-12 A201209-001 BENZONATATE 150MG CAPSULE / ORAL AA RS 2014-09-24 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 A201209-001 BENZONATATE 150MG CAPSULE / ORAL AA RS 2014-09-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201209-001 BENZONATATE 150MG CAPSULE / ORAL AA RS 2014-09-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201209-001 BENZONATATE 150MG CAPSULE / ORAL AA RS 2014-09-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201209-001 BENZONATATE 150MG CAPSULE / ORAL AA RS 2014-09-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201209-001 BENZONATATE 150MG CAPSULE / ORAL AA RS 2014-09-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201209-001 BENZONATATE 150MG CAPSULE / ORAL AA RS 2014-09-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201209-001 BENZONATATE 150MG CAPSULE / ORAL AA RS 2014-09-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201209-001 BENZONATATE 150MG CAPSULE / ORAL AA RS 2014-09-24 ea99ee380514…
Observed Orange Book normalized TE history#