Home NDC 51655-754 Benzonatate
Product NDC 51655-754
11-digit product format 516550754
Labeler code 51655
Product ID 51655-754_49516954-2f3a-7b4a-e063-6394a90a3fa4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzonatate
Dosage form CAPSULE
Route ORAL
Labeler Northwind Health Company, LLC
Application ANDA206948
Marketing category ANDA
Marketing start 2021-07-15
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 A206948-001 BENZONATATE BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 A206948-002 BENZONATATE BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19
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 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA RS 2018-12-19 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA RS 2018-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA 2018-12-19 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA 2018-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA 2018-12-19 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA 2018-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA 2018-12-19 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA 2018-12-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206948-001 BENZONATATE 100MG CAPSULE / ORAL AA 2018-12-19 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A206948-002 BENZONATATE 200MG CAPSULE / ORAL AA 2018-12-19 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
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 51655-754-20 Benzonatate 20 in 1 BOTTLE, PLASTIC CAPSULE 20 4 51655-754-21 Benzonatate 21 in 1 BOTTLE, PLASTIC CAPSULE 21 4 51655-754-52 Benzonatate 30 in 1 BOTTLE, PLASTIC CAPSULE 30 4 51655-754-54 Benzonatate 15 in 1 BOTTLE, PLASTIC CAPSULE 15 4 51655-754-85 Benzonatate 9 in 1 BOTTLE, PLASTIC CAPSULE 9 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51655-754 BENZONATATE CAPSULE [NORTHWIND PHARMACEUTICALS] 3 Current NDC, 5 package rows 20240110_da6bcd14-2294-e7df-e053-2995a90a4526.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 · 23 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 51655-754-20 51655075420 20 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-20) 20 capsule 2021-07-15 No No Current 51655-754-21 51655075421 21 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-21) 21 capsule 2023-05-31 No No Current 51655-754-52 51655075452 30 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-52) 30 capsule 2022-10-05 No No Current 51655-754-54 51655075454 15 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-54) 15 capsule 2022-11-30 No No Current 51655-754-85 51655075485 9 CAPSULE in 1 BOTTLE, PLASTIC (51655-754-85) 9 capsule 2023-12-21 No No Current