benzonatate
- Product NDC
- 53002-0412
- Requested package NDC
- 53002-0412-1
- 11-digit product format
- 530020412
- Labeler code
- 53002
- Product ID
- 53002-0412_daa38471-991b-43e3-8a25-c041105261e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RPK 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
- 2021-12-31
- 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 | 53002-0412 | 53002-0412-1 | 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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-0412-1 | benzonatate | 10 in 1 BOTTLE | CAPSULE | 10 | 6 | |
| 53002-0412-2 | benzonatate | 15 in 1 BOTTLE | CAPSULE | 15 | 6 | |
| 53002-0412-3 | benzonatate | 20 in 1 BOTTLE | CAPSULE | 20 | 6 | |
| 53002-0412-4 | benzonatate | 30 in 1 BOTTLE | CAPSULE | 30 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-0412 | BENZONATATE CAPSULE [RPK PHARMACEUTICALS, INC.] | 6 | Legacy NDC, 4 package rows | 20230609_9e1a2e84-c27a-4cb6-addb-cbe5d4b7d70e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 283417 | benzonatate 200 MG Oral Capsule | PSN | 9e1a2e84-c27a-4cb6-addb-cbe5d4b7d70e | 6 |
| 283417 | benzonatate 200 MG Oral Capsule | SCD | 9e1a2e84-c27a-4cb6-addb-cbe5d4b7d70e | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-0412-1 | 53002041201 | 10 CAPSULE in 1 BOTTLE (53002-0412-1) | 10 capsule | 2019-01-01 | 0000-00-00 | No | No | Current |