Application 040627
- Type
- ANDA
- Sponsor
- THEPHARMANETWORK LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BENZONATATE | BENZONATATE | CAPSULE;ORAL | 100MG | No | Yes |
| 002 | BENZONATATE | BENZONATATE | CAPSULE;ORAL | 100MG | No | Yes |
| 003 | BENZONATATE | BENZONATATE | CAPSULE;ORAL | 150MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040627-001 | BENZONATATE | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-03-30 | |
| A040627-002 | BENZONATATE | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-25 | |
| A040627-003 | BENZONATATE | BENZONATATE | 150MG | CAPSULE / ORAL | AA | RS | 2014-09-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040627-001 | AA |
| A040627-002 | AA |
| A040627-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-03-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | AA | RS | 2014-09-24 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-03-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | AA | RS | 2014-09-24 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-03-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | RS | 2014-09-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-03-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | RS | 2014-09-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-03-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | RS | 2014-09-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-03-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | RS | 2014-09-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-03-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | RS | 2014-09-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-03-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-07-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | RS | 2014-09-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-03-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-07-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | 2014-09-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-03-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-07-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | 2014-09-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-03-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-07-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | 2014-09-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-03-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-07-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | 2014-09-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-03-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040627-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2007-07-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040627-003 | BENZONATATE | 150MG | CAPSULE / ORAL | 2014-09-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040627-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2007-03-30 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040627-001 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040627-002 | AA | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A040627-003 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A040627-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040627-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040627-003 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040627-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040627-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040627-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040627-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040627-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040627-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040627-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040627-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040627-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040627-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040627-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040627-002 | AA | 1 | 03ed91905a0d… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040627-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040627-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040627-003 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040627-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040627-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040627-003 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040627-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040627-002 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040627-003 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040627-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040627-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040627-002 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040627-003 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040627-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040627-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040627-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040627-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040627-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040627-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040627-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040627-001 | AA | 1 | ea99ee380514… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040627-001 | AA | 1 | a67488948f0b… |
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 | Bryant Ranch Prepack | a788cb01-6dc3-4f28-aaa0-c23ac058c39a | 2026-05-28 | Warnings, Adverse reactions | 040627 ANDA040627 71335-0688 |
| BENZONATATE | BENZONATATE | Northwind Health Company, LLC | da807eb3-349e-61b9-e053-2995a90a0e21 | 2026-01-01 | Warnings, Adverse reactions | 040627 ANDA040627 |
| BENZONATATE | BENZONATATE | QPharma, Inc. | 55c4ae18-3e37-4caf-9fdb-9d307970b5f9 | 2025-12-21 | Warnings, Adverse reactions | 040627 ANDA040627 |
| BENZONATATE | BENZONATATE | Coupler LLC | 463d5cff-3cd6-58fc-e063-6394a90a996b | 2025-12-18 | Warnings, Adverse reactions | 040627 ANDA040627 |
| BENZONATATE | BENZONATATE | Ascend Laboratories, LLC | 54374c04-63b9-49fa-b6a2-4a711e322d8e | 2025-12-02 | Warnings, Adverse reactions | 040627 ANDA040627 |
| benzonatate | BENZONATATE | Proficient Rx LP | 9566b9b9-54ef-423c-8ce4-0f1714052158 | 2022-05-01 | Warnings, Adverse reactions | 040627 ANDA040627 71205-971 |
| benzonatate | BENZONATATE | Proficient Rx LP | 9fb78c06-e527-4596-884c-fcf882927a33 | 2020-02-01 | Warnings, Adverse reactions | 040627 ANDA040627 |
| benzonatate | BENZONATATE | Bryant Ranch Prepack | 143a5ba8-0ee9-43be-a0da-2c455c1a46bd | 2019-09-11 | Warnings, Adverse reactions | 040627 ANDA040627 71335-1329 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68071-1984 | benzonatate | benzonatate | NuCare Phamaceuticals, Inc. | ANDA | Current |
| 68071-3204 | benzonatate | benzonatate | NuCarePharmaceuticals,Inc. | ANDA | Current |
| 68071-3346 | benzonatate | benzonatate | Nucare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4276 | benzonatate | benzonatate | NuCare Pharmaceuticals,In | ANDA | Current |
| 68071-4276 | benzonatate | benzonatate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4276 | benzonatate | benzonatate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4317 | benzonatate | benzonatate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4317 | benzonatate | benzonatate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4317 | benzonatate | benzonatate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4337 | benzonatate | benzonatate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4337 | benzonatate | benzonatate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7094 | benzonatate | benzonatate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7094 | benzonatate | benzonatate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7094 | benzonatate | benzonatate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8958 | benzonatate | benzonatate | Preferred Pharmaceuticlas Inc. | ANDA | Current |
| 69336-126 | benzonatate | benzonatate | Sterling-Knight Pharmaceuticals, LLC | ANDA | Current |
| 69336-126 | benzonatate | benzonatate | Sterling-Knight Pharmaceuticals, LLC | ANDA | Current |
| 69336-126 | benzonatate | benzonatate | Sterling-Knight Pharmaceuticals, LLC | ANDA | Current |
| 70518-0729 | benzonatate | benzonatate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0729 | benzonatate | benzonatate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0930 | benzonatate | benzonatate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0930 | benzonatate | benzonatate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0930 | benzonatate | benzonatate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0930 | benzonatate | benzonatate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0930 | benzonatate | benzonatate | REMEDYREPACK INC. | ANDA | Current |
| 70934-121 | benzonatate | benzonatate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-121 | benzonatate | benzonatate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-121 | benzonatate | benzonatate | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-121 | benzonatate | benzonatate | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71205-971 | benzonatate | benzonatate | Proficient Rx LP | ANDA | Current |
| 71205-971 | benzonatate | benzonatate | Proficient Rx LP | ANDA | Current |
| 71335-0688 | benzonatate | benzonatate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0688 | benzonatate | benzonatate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1329 | benzonatate | benzonatate | Bryant Ranch Prepack | ANDA | Current |