Home NDC 0615-8661 Benzonatate
Product NDC 0615-8661
11-digit product format 006158661
Labeler code 0615
Product ID 0615-8661_5e632817-29e3-40f4-805e-9c892b7a34dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzonatate
Dosage form CAPSULE
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application ANDA202765
Marketing category ANDA
Marketing start 2024-07-26
Substance BENZONATATE
Active strength 100 mg/1
Pharmacologic classes Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A202765-001 BENZONATATE BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 A202765-002 BENZONATATE BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25
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 · 86 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 2026-09-14 22:38:34 2026-08 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202765-001 BENZONATATE 200MG CAPSULE / ORAL AA 2015-07-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202765-002 BENZONATATE 100MG CAPSULE / ORAL AA 2017-08-25 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Benzonatate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZONATATE 100 mg/1
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 2 of 2 · 21 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0615-8661-05 00615866105 15 CAPSULE in 1 BLISTER PACK (0615-8661-05) 15 capsule 2026-09-15 No No Current 0615-8661-21 00615866121 21 CAPSULE in 1 BLISTER PACK (0615-8661-21) 21 capsule 2026-09-15 No No Current 0615-8661-39 00615866139 30 CAPSULE in 1 BLISTER PACK (0615-8661-39) 30 capsule 2026-09-15 No No Current