benzonatate
- Product NDC
- 42708-107
- 11-digit product format
- 427080107
- Labeler code
- 42708
- Product ID
- 42708-107_bc06aac1-9303-7cd3-e053-2995a90aa148
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- QPharma Inc
- Application
- ANDA040749
- Marketing category
- ANDA
- Marketing start
- 2017-03-22
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- 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 product | product | 42708-107 | D | Discontinued by firm | 2026-08-17 | ||
| excluded package | package | 42708-107 | 42708-107-30 | D | Discontinued by firm | 2026-08-17 |
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 42708-107-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 42708-107-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 42708-107-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 42708-107-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 42708-107-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 42708-107-30 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 42708-107-30 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 42708-107-30 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 42708-107-30 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 42708-107-30 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 42708-107-30 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 42708-107-30 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A040749-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | RS | 2007-07-25 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | A040749-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | RS | 2007-07-25 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040749-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | RS | 2007-07-25 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040749-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | RS | 2007-07-25 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040749-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | RS | 2007-07-25 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040749-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | RS | 2007-07-25 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040749-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | RS | 2007-07-25 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040749-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | RS | 2007-07-25 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040749-001 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | RS | 2007-07-25 | ea99ee380514… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A040749-001 | AA | 1 | 74a2ff9319b5… |
| 2021-12-28 21:50 UTC | 2021-12 | A040749-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040749-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040749-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040749-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040749-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040749-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040749-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040749-001 | AA | 1 | ea99ee380514… |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-12-20 | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 2023-01-30 | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 2021-03-15 | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 2021-01-29 | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
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 | 040749 ANDA040749 |
| benzonatate | BENZONATATE | Proficient Rx LP | 9566b9b9-54ef-423c-8ce4-0f1714052158 | 2022-05-01 | Warnings, Adverse reactions | 040749 ANDA040749 |
| benzonatate | BENZONATATE | Proficient Rx LP | 27156dad-64d6-4ea4-a3da-29e8e096fb01 | 2020-01-01 | Warnings, Adverse reactions | 040749 ANDA040749 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 42708-107-30 | 42708010730 | 30 CAPSULE in 1 BOTTLE (42708-107-30) | 30 capsule | 2017-03-22 | 0000-00-00 | Yes | No | Current |