Benzonatate
- Product NDC
- 70934-884
- Requested package NDC
- 70934-884-20
- 11-digit product format
- 709340884
- Labeler code
- 70934
- Product ID
- 70934-884_c9d864fd-24ff-05b2-e053-2995a90a8a1f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA206948
- Marketing category
- ANDA
- Marketing start
- 2021-08-18
- Marketing end
- 2024-11-30
- 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#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 70934-884 | 70934-884-20 | D | Discontinued by firm | 2026-08-07 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| A206948-001 | AA |
| A206948-002 | 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 | 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… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206948-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2018-12-19 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A206948-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2018-12-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206948-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2018-12-19 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A206948-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2018-12-19 | 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 | A206948-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206948-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206948-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206948-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206948-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206948-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206948-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206948-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206948-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206948-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206948-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206948-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206948-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206948-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206948-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206948-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206948-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206948-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206948-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206948-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206948-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A206948-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206948-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A206948-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206948-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A206948-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A206948-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A206948-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206948-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A206948-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A206948-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A206948-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A206948-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A206948-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A206948-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206948-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A206948-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A206948-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A206948-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A206948-002 | AA | 1 | 782e0a99824c… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Benzonatate | BENZONATATE | REMEDYREPACK INC. | 23a5de40-76d0-4117-8d31-2b2f8a6b0a28 | 2026-07-30 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | REMEDYREPACK INC. | ed756746-4cbb-4196-a972-5a8c23702b2a | 2026-07-24 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | A-S Medication Solutions | e6f5f2c2-1c59-405c-97bf-ee73740869d2 | 2026-07-01 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | A-S Medication Solutions | 434130e1-c29c-4029-92c6-7d0f7a928e68 | 2026-07-01 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | Major Pharmaceuticals | 324f65ae-09d1-4bd6-9d2b-593035201ecd | 2026-06-30 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | St. Mary's Medical Park Pharmacy | 96250e05-4608-7d5c-e053-2995a90ad57a | 2026-06-02 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | Cardinal Health 107, LLC | b46f231a-65d3-400d-ae6b-3216830807a2 | 2026-04-14 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | Sportpharm LLC | 0e8f2562-2449-430f-85bb-f9195644cdfa | 2026-04-07 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | Preferred Pharmaceuticals Inc | 3309040d-e240-42f6-9c51-5c54604a3896 | 2026-03-19 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | Preferred Pharmaceuticals Inc. | f2cd05a6-2b8b-4731-b97b-b6677fbabbcf | 2026-03-19 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | A-S Medication Solutions | 14550e43-1d1f-4dc1-a3f2-aac0d78a7118 | 2026-02-13 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | Northwind Health Company, LLC | da6bcd14-2294-e7df-e053-2995a90a4526 | 2026-01-01 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | Northwind Health Company, LLC | da6cead3-2859-df03-e053-2a95a90a010b | 2026-01-01 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | QPharma Inc | fbd07fb0-c49c-a838-e053-6394a90a5f0e | 2025-12-03 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | Asclemed USA, Inc. | 25ed5206-b322-486f-9e54-14125f6e74c5 | 2025-04-18 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | RedPharm Drug, Inc. | a2f6acff-70ff-79f1-e053-2a95a90a6005 | 2025-04-09 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | PD-Rx Pharmaceuticals, Inc. | 70e157f2-1670-422c-a70d-f9576e1647ea | 2025-02-05 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | PD-Rx Pharmaceuticals, Inc. | 55b64aee-d4c4-4aad-9016-0dd879e979e6 | 2025-02-05 | Warnings, Adverse reactions | 206948 ANDA206948 |
| Benzonatate | BENZONATATE | PD-Rx Pharmaceuticals, Inc. | 7a5460bf-5242-4726-9dfa-e215529842c3 | 2025-02-05 | Warnings, Adverse reactions | 206948 ANDA206948 |
| BENZONATATE | BENZONATATE | DIRECT RX | bec39717-eb88-6ca1-e053-2a95a90a9d9d | 2025-01-17 | Warnings, Adverse reactions | 206948 ANDA206948 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-884-20 | 70934088420 | 20 CAPSULE in 1 BOTTLE, PLASTIC (70934-884-20) | 20 capsule | 2021-10-01 | 2024-10-31 | No | No | Current |