Home NDC 0615-8403 Benzonatate
Product NDC 0615-8403
11-digit product format 006158403
Labeler code 0615
Product ID 0615-8403_888d70d8-eda7-4bca-b78c-30fc56231aba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzonatate
Dosage form CAPSULE
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA091133
Marketing category ANDA
Marketing start 2016-12-10
Marketing end 2026-10-31
Substance BENZONATATE
Active strength 100 mg/1
Pharmacologic classes Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091133-001 BENZONATATE BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 A091133-002 BENZONATATE BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 82 observed 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 2026-02-19 14:30 UTC 2026-02 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091133-001 BENZONATATE 100MG CAPSULE / ORAL AA 2015-07-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091133-002 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-30 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Benzonatate Active Ingredients# Ingredient, Strength table Ingredient Strength BENZONATATE 100 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197397 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0615-8403-05 Benzonatate 15 in 1 BLISTER PACK CAPSULE 15 6 0615-8403-21 Benzonatate 21 in 1 BLISTER PACK CAPSULE 21 6 0615-8403-39 Benzonatate 30 in 1 BLISTER PACK CAPSULE 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0615-8403 BENZONATATE CAPSULE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] 5 Current NDC, Legacy NDC, 3 package rows 20240814_6f5c19ad-d811-4196-a9c3-4f6b89626b83.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 · 4 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 0615-8403-05 00615840305 15 CAPSULE in 1 BLISTER PACK (0615-8403-05) 15 capsule 2024-07-03 2026-10-31 No No Historical 0615-8403-21 00615840321 21 CAPSULE in 1 BLISTER PACK (0615-8403-21) 21 capsule 2024-02-12 2026-10-31 No No Historical 0615-8403-39 00615840339 30 CAPSULE in 1 BLISTER PACK (0615-8403-39) 30 capsule 2021-10-06 2026-10-31 No No Current