Home NDC 71205-972 benzonatate
Product NDC 71205-972
11-digit product format 712050972
Labeler code 71205
Product ID 71205-972_492a0004-9824-4df9-ab03-a46953aa4fdb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benzonatate
Dosage form CAPSULE
Route ORAL
Labeler Proficient Rx LP
Application ANDA040749
Marketing category ANDA
Marketing start 2017-03-22
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 2026-12-31
Current FDA listing Yes 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# Additional Listing Data#
Finished product Yes
Brand name base benzonatate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZONATATE 200 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-972 BENZONATATE CAPSULE [PROFICIENT RX LP] 2 Current NDC, Legacy NDC, 8 package rows 20220521_9566b9b9-54ef-423c-8ce4-0f1714052158.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 71205-972-00 71205097200 100 CAPSULE in 1 BOTTLE (71205-972-00) 100 capsule 2020-06-04 0000-00-00 No No Current 71205-972-10 71205097210 10 CAPSULE in 1 BOTTLE (71205-972-10) 10 capsule 2020-06-04 0000-00-00 No No Current 71205-972-14 71205097214 14 CAPSULE in 1 BOTTLE (71205-972-14) 14 capsule 2020-06-04 0000-00-00 No No Current 71205-972-15 71205097215 15 CAPSULE in 1 BOTTLE (71205-972-15) 15 capsule 2020-06-04 0000-00-00 No No Current 71205-972-20 71205097220 20 CAPSULE in 1 BOTTLE (71205-972-20) 20 capsule 2020-06-04 0000-00-00 No No Current 71205-972-21 71205097221 21 CAPSULE in 1 BOTTLE (71205-972-21) 21 capsule 2020-06-04 0000-00-00 No No Current 71205-972-30 71205097230 30 CAPSULE in 1 BOTTLE (71205-972-30) 30 capsule 2020-06-04 0000-00-00 No No Current 71205-972-55 71205097255 500 CAPSULE in 1 BOTTLE (71205-972-55) 500 capsule 2020-06-04 0000-00-00 No No Current