Benzonatate
- Product NDC
- 50090-6205
- Requested package NDC
- 50090-6205-5
- 11-digit product format
- 500906205
- Labeler code
- 50090
- Product ID
- 50090-6205_18cdaeb1-e07f-4a3e-8649-a9541ccef8e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Benzonatate
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA211518
- Marketing category
- ANDA
- Marketing start
- 2019-02-22
- Marketing end
- 0000-00-00
- Substance
- BENZONATATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 50090-6205 | 50090-6205-5 | D | Discontinued by firm | 2026-08-17 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 50090-6205 | 50090-6205-5 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211518-001 | BENZONATATE | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | |
| A211518-002 | BENZONATATE | BENZONATATE | 150MG | CAPSULE / ORAL | AA | 2019-02-22 | |
| A211518-003 | BENZONATATE | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211518-001 | AA |
| A211518-002 | AA |
| A211518-003 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | AA | 2019-02-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | 2019-02-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | 2019-02-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | 2019-02-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | 2019-02-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | 2019-02-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | 2019-02-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | 2019-02-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | 2019-02-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | 2019-02-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | 2019-02-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | 2019-02-22 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211518-002 | BENZONATATE | 150MG | CAPSULE / ORAL | 2019-02-22 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211518-003 | BENZONATATE | 200MG | CAPSULE / ORAL | AA | 2019-02-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211518-001 | BENZONATATE | 100MG | CAPSULE / ORAL | AA | 2019-02-22 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A211518-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211518-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211518-003 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211518-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211518-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211518-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211518-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211518-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211518-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211518-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211518-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211518-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211518-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211518-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211518-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211518-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211518-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211518-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211518-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211518-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211518-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A211518-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A211518-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211518-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211518-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211518-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211518-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211518-001 | AA | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211518-003 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A211518-001 | AA | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A211518-003 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211518-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211518-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A211518-003 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A211518-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A211518-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A211518-003 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A211518-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A211518-002 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A211518-003 | AA | 1 | 4b0b4de00fa7… |
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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-6205-0 | EA - Each | 50090-6205 | c880ae08-f946-48d3-bc95-b28379bd382f | 1 | 2022-12-07 |
| 50090-6205-1 | EA - Each | 50090-6205 | 1c5a6c0b-9928-4230-b353-965c178a39d4 | 1 | 2022-12-07 |
| 50090-6205-2 | EA - Each | 50090-6205 | af58c3d6-5983-4db8-a723-0326cdce2d7a | 1 | 2022-12-07 |
| 50090-6205-5 | EA - Each | 50090-6205 | df93e2ca-af2b-40b5-95b3-7f9329eb7982 | 1 | 2022-12-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-6205 | BENZONATATE CAPSULE [A-S MEDICATION SOLUTIONS] | 4 | Legacy NDC | 20231101_835d015a-ed21-41c5-8eee-0a47078f9796.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Benzonatate | BENZONATATE | Sportpharm LLC | df48d617-a3c2-4776-937d-ccfca651d4fc | 2026-07-23 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | da093b5e-83a7-467e-9716-bc5827a18c20 | 2026-06-30 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 865a6317-c697-4dbe-9074-4a955036cdd7 | 2026-06-29 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | 0f91fd98-1a86-42aa-8055-d339bff73015 | 2026-06-26 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Anvi Pharmaceuticals Inc | 7c733168-355e-4753-8d52-59a06fb39952 | 2026-05-13 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Redpharm drug, inc | f3c23663-0cb7-ffa4-e053-2a95a90a9ae0 | 2026-05-13 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Camber Pharmaceuticals, Inc. | c21afd18-3b04-4f15-874b-25e0c768f801 | 2026-05-11 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | XLCare Pharmaceuticals, Inc. | e33afd96-5ad3-4033-b067-981ac2ed2bea | 2026-05-11 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Preferred Pharmaceuticals, Inc. | fe5e8a94-ac75-4657-a45a-1fe94dbe0d43 | 2026-03-19 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Bryant Ranch Prepack | da8fcba7-a43e-4463-96ac-104c7613d64f | 2026-03-11 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Direct_rx | 2b4b22e9-a03d-fb8f-e063-6394a90a8747 | 2026-02-24 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | REMEDYREPACK INC. | 9815f3f4-fb46-4796-a0ed-62a9e098286d | 2026-02-10 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | A-S Medication Solutions | 3268cde5-65ae-43d2-95c6-b8bb4c32a6fd | 2024-10-21 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | NuCare Pharmaceuticals,Inc. | cfd54d90-c15d-0d02-e053-2995a90a8b28 | 2024-09-30 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Proficient Rx LP | 47560d98-f4c4-4738-85fe-41cbed09ed59 | 2022-09-01 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Proficient Rx LP | 8dcaeabf-e7da-4e0c-b6db-0bd425d6506e | 2022-07-01 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Proficient Rx LP | 45d9b32a-3198-49d5-addf-f077fec50b9c | 2022-06-01 | Warnings, Adverse reactions | 211518 ANDA211518 |
| Benzonatate | BENZONATATE | Proficient Rx LP | f4337699-3279-4c08-94f4-caba6d866f63 | 2022-03-01 | Warnings, Adverse reactions | 211518 ANDA211518 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-6205-5 | 50090620505 | 15 CAPSULE in 1 BOTTLE (50090-6205-5) | 15 capsule | 2022-11-04 | 0000-00-00 | No | No | Current |