Home NDC 67296-1583-3 benzonatate
Product NDC 67296-1583
Requested package NDC 67296-1583-3
11-digit product format 672961583
Labeler code 67296
Product ID 67296-1583_9c9fd8a4-488c-75a5-e053-2995a90a626a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benzonatate
Dosage form CAPSULE
Route ORAL
Labeler RedPharm Drug, Inc.
Application ANDA040749
Marketing category ANDA
Marketing start 2018-01-01
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 2021-12-31
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 · 7 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 67296-1583 67296-1583-3 I Inactivated by FDA excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 67296-1583 67296-1583-3 I Inactivated by FDA excluded / ndc_excluded.zip 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 67296-1583 67296-1583-3 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 67296-1583 67296-1583-3 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 67296-1583 67296-1583-3 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 67296-1583 67296-1583-3 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 67296-1583 67296-1583-3 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
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 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040749-001 BENZONATATE 200MG CAPSULE / ORAL AA RS 2007-07-25 ea99ee380514…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67296-1583-3 benzonatate 30 in 1 BOTTLE CAPSULE 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67296-1583 BENZONATATE CAPSULE [REDPHARM DRUG, INC.] 3 Legacy NDC, 1 package rows 20240816_6a100c5c-ec5e-29a3-e053-2991aa0aa3b0.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 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67296-1583-3 67296158303 30 CAPSULE in 1 BOTTLE (67296-1583-3) 30 capsule 2018-01-01 0000-00-00 No No Current