Benzonatate
- Product NDC
- 55154-7995
- Requested package NDC
- 55154-7995-0
- 11-digit product format
- 551547995
- Labeler code
- 55154
- Product ID
- 55154-7995_761ce0b3-1ae1-4a95-8a66-617b76fdb81e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA040597
- Marketing category
- ANDA
- Marketing start
- 2007-09-04
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- 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 | 55154-7995 | 55154-7995-0 | 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… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040597-001 | BENZONATATE | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | |
| A040597-002 | BENZONATATE | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040597-001 | AA |
| A040597-002 | 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 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A040597-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2007-06-08 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A040597-002 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2007-06-08 | 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 | A040597-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040597-002 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040597-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040597-002 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040597-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040597-002 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040597-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040597-002 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040597-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040597-002 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040597-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040597-002 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040597-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040597-002 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040597-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040597-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040597-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040597-002 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040597-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040597-002 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040597-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040597-002 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040597-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040597-002 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040597-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040597-002 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040597-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A040597-002 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040597-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040597-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040597-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A040597-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040597-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A040597-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040597-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A040597-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040597-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A040597-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040597-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A040597-002 | 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 | Zydus Pharmaceuticals USA Inc. | 331c70dc-005e-4d96-a35c-4d2d810aa3b1 | 2026-03-23 | Warnings, Adverse reactions | 040597 ANDA040597 |
| Benzonatate | BENZONATATE | Preferred Pharmaceuticals Inc. | 6f7f4a31-99ec-45ca-84d7-0be3640d1e0b | 2026-03-19 | Warnings, Adverse reactions | 040597 ANDA040597 |
| Benzonatate | BENZONATATE | Major Pharmaceuticals | 2256f7e4-b7e6-433f-941e-bf78ddcd55b2 | 2026-03-18 | Warnings, Adverse reactions | 040597 ANDA040597 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | b3b16ea5-4572-470e-8124-fc38b1d49e3e | 2026-03-11 | Warnings, Adverse reactions | 040597 ANDA040597 |
| Benzonatate | BENZONATATE | Redpharm Drug | 32524a8a-4cee-26c0-e063-6294a90aa898 | 2025-12-18 | Warnings, Adverse reactions | 040597 ANDA040597 |
| Benzonatate | BENZONATATE | A-S Medication Solutions | 1b5364d2-bbd5-4c05-a7b5-a5cdbf1d37e9 | 2025-12-01 | Warnings, Adverse reactions | 040597 ANDA040597 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 751d9d60-cd6b-4aa1-b68f-61b86c4059ad | 2025-08-26 | Warnings, Adverse reactions | 040597 ANDA040597 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 995ebc53-4e13-4c1d-b301-71ac83c6def8 | 2025-06-04 | Warnings, Adverse reactions | 040597 ANDA040597 |
| BENZONATATE | BENZONATATE | DIRECT RX | 673bf826-a005-7a38-e053-2991aa0a4cb5 | 2025-02-17 | Warnings, Adverse reactions | 040597 ANDA040597 |
| Benzonatate | BENZONATATE | Zydus Lifesciences Limited | abb4360a-4c52-45b6-9b80-df3c1bfc4c59 | 2024-11-25 | 040597 ANDA040597 | |
| Benzonatate | BENZONATATE | American Health Packaging | 9a71725a-64b6-4800-a79c-aa4b2d74d44f | 2024-09-30 | Warnings, Adverse reactions | 040597 ANDA040597 |
| Benzonatate | BENZONATATE | A-S Medication Solutions | b87a7e18-bb47-4b25-be9e-6200fb73b4b4 | 2023-12-07 | Warnings, Adverse reactions | 040597 ANDA040597 |
| Benzonatate | BENZONATATE | Proficient Rx LP | a7b12862-1c9f-4712-93e6-a859b24728c2 | 2019-11-01 | Warnings, Adverse reactions | 040597 ANDA040597 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55154-7995-0 | 55154799500 | 10 BLISTER PACK in 1 BAG (55154-7995-0) > 1 CAPSULE in 1 BLISTER PACK | 10 blister pack | 2007-09-04 | 0000-00-00 | No | No | Current |