Home NDC 67877-574 benzonatate
Product NDC 67877-574
11-digit product format 678770574
Labeler code 67877
Product ID 67877-574_30b1db37-0e38-428e-a568-6ccc3ec605a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benzonatate
Dosage form CAPSULE
Route ORAL
Labeler Ascend Laboratories LLC
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 · 20 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 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 67877-574-01 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 67877-574-01 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 67877-574-01 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 67877-574-01 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 67877-574-01 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 67877-574-01 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 67877-574-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 67877-574-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 67877-574-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 67877-574-01 8dfbde2a14a4…c9ff85d89658…
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# FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67877-574-01 67877057401 100 CAPSULE in 1 BOTTLE (67877-574-01) 100 capsule 2017-03-22 0000-00-00 No No Current