NDC 68546-165 - Austedo
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68546-165
- Package NDCs from labels
- 68546-165-15
- Manufacturer
- Teva Neuroscience, Inc.
- Effective date
- 2025-02-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Austedo - Teva Neuroscience, Inc. | Teva Neuroscience, Inc. | 2025-02-28 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68546-165-15 | AUSTEDO XR | 14 in 1 BLISTER PACK | TABLET, FILM COATED, EXTENDED RE | 14 | 24 mg | 35 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68546-165 | AUSTEDO (DEUTETRABENAZINE) TABLET, COATED AUSTEDO (DEUTETRABENAZINE) KIT AUSTEDO XR (DEUTETRABENAZINE) TABLET, FILM COATED, EXTENDED RELEASE [TEVA NEUROSCIENCE, INC.] | 35 | Unmatched | 20250322_7ea3c60a-45c7-44cc-afc2-d87fa53993c0.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 |
|---|---|---|---|---|---|---|
| Quality Choice Instant Ear Dry | ISOPROPYL ALCOHOL | Chain Drug Manufacturing Association | 9d3c681b-a941-6ddb-e053-2a95a90ad3bf | 2023-12-20 | Warnings | ND2M416302 |
| Premiere Value Ear Drops for Swimmers | ISOPROPYL ALCOHOL | Pharmacy Value Alliance; LLC | 9d606fe6-ae57-724f-e053-2a95a90abffe | 2023-12-20 | Warnings | ND2M416302 |
| CVS Ear Drops for Swimmers | ISOPROPYL ALCOHOL | CVS Pharmacy | cc4614ee-5d6e-4a07-9826-aff12cc35abd | 2023-12-20 | Warnings | ND2M416302 |
| Walgreens Multi-Symptom Relief Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE | Walgreen Co. | a03789ce-66bd-7b12-e053-2995a90af85a | 2023-12-20 | Warnings | 3NXW29V3WO |
| Walgreens Lubricant Eye Drops Preservative Free | DEXTRAN 70, HYPROMELLOSE | Walgreen Company | 9b383e41-e116-1c12-e053-2a95a90ab25f | 2023-12-20 | Warnings | 3NXW29V3WO |
| Walgreens Eye Drops Advanced Relief 15mL | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI | Walgreen Company | 949f5560-fba7-2da8-e053-2995a90a23c2 | 2023-12-20 | Warnings | FZ989GH94E |
| Walgreens Lubricant Eye Drops High Performance 15mL and twin pack | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Walgreen Company | 94ee8310-1c19-dfd4-e053-2a95a90a8356 | 2023-12-20 | Warnings | 6DC9Q167V3 |
| Walgreens Lubricant Eye Drops Dry Eye 15mL and twin pack | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Walgreen Company | 94f6e1cd-073c-61ca-e053-2a95a90ae725 | 2023-12-20 | Warnings | 6DC9Q167V3 |
| Signature Care Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Better Living Brands LLC | 5d7228ce-f108-4cc2-9aec-8b4548c3a155 | 2023-12-20 | Warnings | FZ989GH94E |
| Kroger High Performance Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Kroger | d2aa8963-1922-02f3-e053-2a95a90a7d93 | 2023-12-20 | Warnings | 6DC9Q167V3 |
| Kroger Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Kroger Company | f7ad77fc-d890-25b9-e053-6394a90a2b12 | 2023-12-20 | Warnings | FZ989GH94E |
| TopCare Health Dry Eye Relief Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | Topco Associates LLC | 9c617e34-fc66-1a5b-e053-2995a90ace2c | 2023-12-20 | Warnings | 3NXW29V3WO |
| Equaline Advanced Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | United Natural Foods, Inc. | f7602789-179a-edfc-e053-6294a90a0844 | 2023-12-20 | Warnings | FZ989GH94E |
| Topcare Health Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | Topco Associates LLC | 9c614c0e-5862-682f-e053-2a95a90abc09 | 2023-12-20 | Warnings | 532B59J990 FZ989GH94E |
| Topcare Health Lubricant Eye Drops | POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL | Topco Assoc LLC | 9c6284f9-00bb-37b5-e053-2a95a90ae2ee | 2023-12-20 | Warnings | 6DC9Q167V3 |
| HEB Dry Eye Eye Drops | GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400 | HEB | f80023cf-8e42-780a-e053-6294a90a66cd | 2023-12-20 | Warnings | 3NXW29V3WO |
| TopCare Health Advanced Moisturizing Plus Redness Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Topco Associates LLC | 9c6193a6-d822-1b27-e053-2995a90ab3cf | 2023-12-20 | Warnings | FZ989GH94E |
| HEB Advanced Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | HEB Grocery Company, LP | f76281d6-3aea-349b-e053-6394a90afca2 | 2023-12-20 | Warnings | FZ989GH94E |
| Coola Bare Republic Mineral Face-Lotion SPF 70 | TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8% | COOLA LLC | a334a61d-5c5a-4f45-b202-6dd7bb3d250b | 2023-12-20 | Warnings | 15FIX9V2JP |
| Bare Republic Big Adventure Stick SPF 70 | TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9% | COOLA | e800f72f-8c8b-4a12-843f-1ee404055cf0 | 2023-12-20 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.