benzonatate
- Product NDC
- 49999-552
- 11-digit product format
- 499990552
- Labeler code
- 49999
- Product ID
- 49999-552_d5f6ab45-dc2c-459e-8c48-db861223e10d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Lake Erie Medical DBA Quality Care Products 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
- 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 | 49999-552 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 49999-552 | 49999-552-15 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 49999-552 | 49999-552-20 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 49999-552 | 49999-552-30 | D | Discontinued by firm | 2026-07-31 | |
| excluded package | package | 49999-552 | 49999-552-60 | 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 |
|---|---|---|---|---|---|
| 49999-552-15 | EA - Each | 49999-552 | 56a9e537-ac89-4378-9a93-9e812db54992 | 1 | 2013-09-04 |
| 49999-552-20 | EA - Each | 49999-552 | 0e4a9229-1daa-4866-bc07-7227f03bc662 | 1 | 2016-12-07 |
| 49999-552-30 | EA - Each | 49999-552 | 4f107240-ad77-4f86-99b7-a53f9d668dec | 1 | 2013-02-13 |
| 49999-552-60 | EA - Each | 49999-552 | 271296ab-78d4-4ae6-9319-1a8421e20cfa | 1 | 2014-01-04 |