Home NDC 63187-606 Benzonatate
Product NDC 63187-606
11-digit product format 631870606
Labeler code 63187
Product ID 63187-606_ab1812ff-a83c-466e-944b-c81630d1c8fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzonatate
Dosage form CAPSULE
Route ORAL
Labeler Proficient Rx LP
Application ANDA202765
Marketing category ANDA
Marketing start 2015-08-10
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 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 63187-606 BENZONATATE CAPSULE [PROFICIENT RX LP] 5 Current NDC, Legacy NDC, 6 package rows 20221029_3296f664-8de0-4ccc-8346-ed2b1b0db027.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 2 of 2 · 21 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 63187-606-14 63187060614 14 CAPSULE in 1 BOTTLE (63187-606-14) 14 capsule 2015-12-01 0000-00-00 No No Current 63187-606-20 63187060620 20 CAPSULE in 1 BOTTLE (63187-606-20) 20 capsule 2015-12-01 0000-00-00 No No Current 63187-606-21 63187060621 21 CAPSULE in 1 BOTTLE (63187-606-21) 21 capsule 2017-11-01 0000-00-00 No No Current 63187-606-30 63187060630 30 CAPSULE in 1 BOTTLE (63187-606-30) 30 capsule 2015-12-01 0000-00-00 No No Current 63187-606-40 63187060640 40 CAPSULE in 1 BOTTLE (63187-606-40) 40 capsule 2015-12-01 0000-00-00 No No Current 63187-606-60 63187060660 60 CAPSULE in 1 BOTTLE (63187-606-60) 60 capsule 2015-12-01 0000-00-00 No No Current