Benzonatate
- Product NDC
- 70934-943
- Requested package NDC
- 70934-943-30
- 11-digit product format
- 709340943
- Labeler code
- 70934
- Product ID
- 70934-943_f15fe303-883e-3ce5-e053-2a95a90a1de8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA081297
- Marketing category
- ANDA
- Marketing start
- 2022-02-09
- Marketing end
- 2023-06-30
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70934-943 | 70934-943-30 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70934-943 | 70934-943-30 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70934-943 | 70934-943-30 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70934-943 | 70934-943-30 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70934-943 | 70934-943-30 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A081297-001 | BENZONATATE | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | |
| A081297-002 | BENZONATATE | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A081297-001 | AA |
| A081297-002 | AA |
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.
| 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 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A081297-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 1993-01-29 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A081297-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-10-30 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A081297-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A081297-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A081297-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A081297-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A081297-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A081297-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A081297-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A081297-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A081297-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A081297-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A081297-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A081297-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A081297-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A081297-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A081297-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A081297-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A081297-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A081297-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A081297-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A081297-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A081297-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A081297-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A081297-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A081297-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A081297-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A081297-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A081297-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A081297-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A081297-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A081297-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A081297-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A081297-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A081297-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A081297-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A081297-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A081297-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A081297-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A081297-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A081297-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A081297-002 | AA | 1 | 782e0a99824c… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 5728b147-33a0-4534-b936-3e02274d9467 | 2026-07-15 | Warnings, Adverse reactions | 081297 ANDA081297 |
| Benzonatate | BENZONATATE | Golden State Medical Supply, Inc. | d580b1c9-d450-4032-acb2-0563c589ed2c | 2026-07-06 | Warnings, Adverse reactions | 081297 ANDA081297 |
| Benzonatate | BENZONATATE | Bionpharma Inc. | 2630be01-1d2d-4c40-8e56-8568ea89eacf | 2026-06-23 | Warnings, Adverse reactions | 081297 ANDA081297 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 540d2bc6-11dc-43d7-b616-b89d75b81cd1 | 2026-05-15 | Warnings, Adverse reactions | 081297 ANDA081297 |
| Benzonatate | BENZONATATE | Coupler LLC | 2ce035ff-42cb-d8ef-e063-6294a90a0c06 | 2025-01-29 | Warnings, Adverse reactions | 081297 ANDA081297 |
| Benzonatate | BENZONATATE | NuCare Pharmaceuticals,Inc. | 9cab4544-e0ab-3fdd-e053-2995a90ad049 | 2024-06-20 | Warnings, Adverse reactions | 081297 ANDA081297 |
| Benzonatate | BENZONATATE | NuCare Pharmaceuticals,Inc. | 96b260c3-e177-73c3-e053-2a95a90a775e | 2024-06-19 | Warnings, Adverse reactions | 081297 ANDA081297 |
| Benzonatate | BENZONATATE | Aphena Pharma Solutions - Tennessee, LLC | 3bd33aec-9a30-4581-bd28-6cfb67772cef | 2023-03-15 | Warnings, Adverse reactions | 081297 ANDA081297 |
| Benzonatate | BENZONATATE | Proficient Rx LP | bc435603-ddc4-4083-af09-2e562defbe7f | 2022-05-02 | Warnings, Adverse reactions | 081297 ANDA081297 |
| Benzonatate | BENZONATATE | Proficient Rx LP | 0d14cbf4-f43f-4ad2-8e8b-7a844e417702 | 2020-01-01 | Warnings, Adverse reactions | 081297 ANDA081297 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-943-30 | 70934094330 | 30 CAPSULE in 1 BOTTLE, PLASTIC (70934-943-30) | 30 capsule | 2022-02-09 | 2023-06-30 | No | No | Current |