benzonatate
- Product NDC
- 0440-5186
- 11-digit product format
- 004405186
- Labeler code
- 0440
- Product ID
- 0440-5186_21751aed-a74f-46b7-bd18-d43c5cc40d86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Liberty Pharmaceuticals, 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
- 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 product | product | 0440-5186 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0440-5186 | 0440-5186-01 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0440-5186 | 0440-5186-05 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 0440-5186 | 0440-5186-21 | D | Discontinued by firm | 2026-07-31 |
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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0440-5186-01 | EA - Each | 0440-5186 | 4dfb0ccc-b65a-4bc1-a181-12952858596d | 1 | 2019-11-12 |
| 0440-5186-05 | EA - Each | 0440-5186 | fa2c5539-db0f-41e3-ad60-8b11d5d3e8b1 | 1 | 2019-11-12 |
| 0440-5186-21 | EA - Each | 0440-5186 | 7da1749a-59af-46f7-939f-1a28f3f2e4d7 | 1 | 2019-11-12 |