benzonatate
- Product NDC
- 70934-078
- Requested package NDC
- 70934-078-30
- 11-digit product format
- 709340078
- Labeler code
- 70934
- Product ID
- 70934-078_b815406b-b482-59af-e053-2995a90a9aa6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA040749
- Marketing category
- ANDA
- Marketing start
- 2018-02-09
- 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#
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 | 70934-078 | 70934-078-30 | I | Inactivated by FDA | 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 Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 70934-078-20 | 2023-01-30 | C162847 | 48780-1 | f386c64a-24d6-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
| 70934-078-30 | 2023-01-30 | C162847 | 48780-1 | f386c64a-24d6-0266-e053-dadaa90a7c1a | Benzonatate Capsules, USP 100 mg, 150 mg and 200 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70934-078-20 | benzonatate | 20 in 1 BOTTLE, PLASTIC | CAPSULE | 20 | 3 | |
| 70934-078-30 | benzonatate | 30 in 1 BOTTLE, PLASTIC | CAPSULE | 30 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70934-078-20 | EA - Each | 70934-078 | 3e775fc8-0135-4e6a-862e-981df7341499 | 1 | 2018-05-09 |
| 70934-078-30 | EA - Each | 70934-078 | 289e7385-c642-454f-abe7-95bbd93d8ca9 | 1 | 2018-05-09 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283417 | benzonatate 200 MG Oral Capsule | PSN | 691cee22-9e7a-ffdb-e053-2a91aa0aa08e | 3 |
| 283417 | benzonatate 200 MG Oral Capsule | SCD | 691cee22-9e7a-ffdb-e053-2a91aa0aa08e | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-078-30 | 70934007830 | 30 CAPSULE in 1 BOTTLE, PLASTIC (70934-078-30) | 30 capsule | 2018-02-09 | 0000-00-00 | No | No | Current |