Cotempla XR-ODT
- Product NDC
- 70165-200
- 11-digit product format
- 701650200
- Labeler code
- 70165
- Product ID
- 70165-200_3f8e1342-96a7-1d02-e063-6394a90a3903
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate
- Dosage form
- TABLET, ORALLY DISINTEGRATING
- Route
- ORAL
- Labeler
- Neos Therapeutics Brands, LLC
- Application
- NDA205489
- Marketing category
- NDA
- Marketing start
- 2017-06-20
- Substance
- METHYLPHENIDATE
- Active strength
- 17.3 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cotempla XR-ODT
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE | 17.3 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 207ZZ9QZ49 |
| Rxcui | 1926840, 1926847, 1926849, 1926851, 1926853, 1926855 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70165-200-30 | Cotempla XR-ODT | 6 in 1 BLISTER PACK | TABLET, ORALLY DISINTEGRATING | 6 | | 15 |
| 70165-200-30 | Cotempla XR-ODT | 5 in 1 CARTON | TABLET, ORALLY DISINTEGRATING | 5 | | 15 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70165-200 | COTEMPLA XR-ODT (METHYLPHENIDATE) TABLET, ORALLY DISINTEGRATING [NEOS THERAPEUTICS BRANDS, LLC] | 12 | Current NDC, Legacy NDC, 2 package rows | 20241109_33f70f58-c871-42c8-8adb-345caeafefcd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70165-200-30 | 70165020030 | 5 BLISTER PACK in 1 CARTON (70165-200-30) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK | 5 blister pack | 2017-06-20 | 0000-00-00 | No | No | Current |