benzonatate
- Product NDC
- 67877-106
- Requested package NDC
- 67877-106-05
- 11-digit product format
- 678770106
- Labeler code
- 67877
- Product ID
- 67877-106_de64cd7e-65b6-4ba2-8ed7-a1c98f2cca4e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Ascend Laboratories LLC
- Application
- ANDA040749
- Marketing category
- ANDA
- Marketing start
- 2007-07-25
- 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
- 2020-12-31
- 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 | 67877-106 | 67877-106-05 | I | Inactivated by FDA | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 67877-106 | 67877-106-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 67877-106 | 67877-106-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | cdf11ea48f46… | ba0047e9e063… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 67877-106 | 67877-106-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 302b2466d912… | e7b80fea0513… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 67877-106 | 67877-106-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 67877-106 | 67877-106-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 67877-106 | 67877-106-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 67877-106 | 67877-106-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 67877-106 | 67877-106-05 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 834df4deac94… | adcc014656a3… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 1332a3947898… | d4bfe170f9cd… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | bd6a592717d7… | 303034d00443… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 67877-106 | 67877-106-05 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8dfbde2a14a4… | c9ff85d89658… |
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… |
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 | 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 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| dc429dc2-e942-6686-8d72-b63c57e806aa | Product name | 5 | 20190416 |
| d45c2ed6-126c-dd22-afd2-e29a2ecf77b9 | Product name | 3 | 20190215 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67877-106-01 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1638-fd44-e053-dadaa90aa01b | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 67877-106-05 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-1638-fd44-e053-dadaa90aa01b | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67877-106-01 | benzonatate | 100 in 1 BOTTLE | CAPSULE | 100 | 13 | |
| 67877-106-05 | benzonatate | 500 in 1 BOTTLE | CAPSULE | 500 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 67877-106-01 | EA - Each | 67877-106 | d87ceff9-b877-403b-a0a7-cf0123b10e92 | 1 | 2012-07-24 |
| 67877-106-05 | EA - Each | 67877-106 | 49f232d1-9f80-40e3-a327-afa6d05bf337 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 67877-106-05 | 67877010605 | 500 CAPSULE in 1 BOTTLE (67877-106-05) | 500 capsule | 2007-07-25 | 0000-00-00 | No | No | Current |