Home NDC 71335-0725 benzonatate
Product NDC 71335-0725
11-digit product format 713350725
Labeler code 71335
Product ID 71335-0725_1c471368-6338-4e1e-b93d-8fcb5022a1f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name benzonatate
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
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 2027-12-31 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 71335-0725 BENZONATATE CAPSULE [BRYANT RANCH PREPACK] 4 Current NDC, Legacy NDC, 9 package rows 20190813_a788cb01-6dc3-4f28-aaa0-c23ac058c39a.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 71335-0725-0 71335072500 6 CAPSULE in 1 BOTTLE (71335-0725-0) 6 capsule 2026-05-28 0 Current 71335-0725-1 71335072501 30 CAPSULE in 1 BOTTLE (71335-0725-1) 30 capsule 2018-03-13 0000-00-00 No No Current 71335-0725-2 71335072502 100 CAPSULE in 1 BOTTLE (71335-0725-2) 100 capsule 2018-03-13 0000-00-00 No No Current 71335-0725-3 71335072503 45 CAPSULE in 1 BOTTLE (71335-0725-3) 45 capsule 2018-03-13 0000-00-00 No No Current 71335-0725-4 71335072504 20 CAPSULE in 1 BOTTLE (71335-0725-4) 20 capsule 2018-03-13 0000-00-00 No No Current 71335-0725-5 71335072505 15 CAPSULE in 1 BOTTLE (71335-0725-5) 15 capsule 2018-03-13 0000-00-00 No No Current 71335-0725-6 71335072506 21 CAPSULE in 1 BOTTLE (71335-0725-6) 21 capsule 2018-03-13 0000-00-00 No No Current 71335-0725-7 71335072507 60 CAPSULE in 1 BOTTLE (71335-0725-7) 60 capsule 2018-03-13 0000-00-00 No No Current 71335-0725-8 71335072508 50 CAPSULE in 1 BOTTLE (71335-0725-8) 50 capsule 2018-03-13 0000-00-00 No No Current 71335-0725-9 71335072509 90 CAPSULE in 1 BOTTLE (71335-0725-9) 90 capsule 2018-03-13 0000-00-00 No No Current