Home NDC 68071-5083 Benzonatate
Product NDC 68071-5083
11-digit product format 680715083
Labeler code 68071
Product ID 68071-5083_5b76326f-7c79-64db-e063-6394a90adfad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Benzonatate
Dosage form CAPSULE
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA206948
Marketing category ANDA
Marketing start 2018-12-21
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
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-5083-3 Benzonatate 30 in 1 BOTTLE CAPSULE 30 4 68071-5083-5 Benzonatate 15 in 1 BOTTLE CAPSULE 15 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-5083 BENZONATATE CAPSULE [NUCARE PHARMACEUTICALS,INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240621_94e0ac6f-8c5a-1fdb-e053-2a95a90a3946.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 Marketing end Sample Exclude flag Status 68071-5083-2 68071508302 20 CAPSULE in 1 BOTTLE (68071-5083-2) 20 capsule 2026-09-14 No No Current 68071-5083-3 68071508303 30 CAPSULE in 1 BOTTLE (68071-5083-3) 30 capsule 2019-10-14 0000-00-00 No No Current 68071-5083-5 68071508305 15 CAPSULE in 1 BOTTLE (68071-5083-5) 15 capsule 2019-10-14 0000-00-00 No No Current