Home NDC 64380-713 Benzonatate
Product NDC 64380-713
11-digit product format 643800713
Labeler code 64380
Product ID 64380-713_21343425-d42f-4a46-ba47-30cedc9fe876
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzonatate
Dosage form CAPSULE
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA091133
Marketing category ANDA
Marketing start 2016-12-10
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product 64380-713 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 64380-713 64380-713-06 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 64380-713 64380-713-07 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
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
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 64380-713-06 2022-09-08 Benzonatate Capsules, USP 64380-713-06 2022-09-08 Benzonatate Capsules, USP 64380-713-07 2022-09-08 Benzonatate Capsules, USP 64380-713-07 2022-09-08 Benzonatate Capsules, USP 64380-713-06 2022-07-29 Benzonatate Capsules, USP 64380-713-06 2022-07-29 Benzonatate Capsules, USP 64380-713-07 2022-07-29 Benzonatate Capsules, USP 64380-713-07 2022-07-29 Benzonatate Capsules, USP
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64380-713-06 Benzonatate 100 in 1 CONTAINER CAPSULE 100 9 64380-713-07 Benzonatate 500 in 1 BOTTLE CAPSULE 500 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-713 BENZONATATE CAPSULE [STRIDES PHARMA SCIENCE LIMITED] 9 Current NDC, Legacy NDC, 2 package rows 20250311_89f5d18e-5ef4-42a3-bc6f-abf4f308462b.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 64380-713-06 64380071306 100 CAPSULE in 1 CONTAINER (64380-713-06) 100 capsule 2016-12-10 0000-00-00 No No Current 64380-713-07 64380071307 500 CAPSULE in 1 BOTTLE (64380-713-07) 500 capsule 2016-12-16 0000-00-00 No No Current