Benzonatate
- Product NDC
- 51655-770
- 11-digit product format
- 516550770
- Labeler code
- 51655
- Product ID
- 51655-770_4a29020f-31db-212b-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Northwind Pharmaceuticals, LLC
- Application
- ANDA040749
- Marketing category
- ANDA
- Marketing start
- 2014-07-25
- 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
- 2019-12-31
- 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 product | product | 51655-770 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 51655-770 | 51655-770-20 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 51655-770 | 51655-770-52 | D | Discontinued by firm | 2026-08-03 |
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51655-770-20 | 2026-01-08 | C162847 | 48780-1 | 9d75b9cf-d26b-f424-e053-dadaa90a57ce | Benzonatate |
| 51655-770-52 | 2026-01-08 | C162847 | 48780-1 | 9d75b9cf-d26b-f424-e053-dadaa90a57ce | Benzonatate |
| 51655-770-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d26b-f424-e053-dadaa90a57ce | Benzonatate |
| 51655-770-52 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d26b-f424-e053-dadaa90a57ce | Benzonatate |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BENZONATATE | ACTIVE INGREDIENT | 5P4DHS6ENR | BENZONATATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC] | 2 | |
| BENZONATATE | ACTIVE MOIETY | 5P4DHS6ENR | BENZONATATE CAPSULE [NORTHWIND PHARMACEUTICALS, LLC] | 2 |