Dexmethylphenidate Hydrochloride
- Product NDC
- 0527-8111
- 11-digit product format
- 005278111
- Labeler code
- 0527
- Product ID
- 0527-8111_05dde601-77db-4253-be20-c4737687633e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- dexmethylphenidate hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA210279
- Marketing category
- ANDA
- Marketing start
- 2018-10-09
- Substance
- DEXMETHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 30 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
- Dexmethylphenidate Hydrochloride
- Brand name suffix
- Extended-Release
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXMETHYLPHENIDATE HYDROCHLORIDE | 30 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 1678OK0E08 |
| Rxcui | 899439, 899461, 899485, 899495, 899511, 1006608, 1101926, 1101932 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 1ff349b0-f325-4585-9c0d-7dc58eb1bc1b | Product name | 1 | 20210818 |
| 7d5b6b15-5a1e-e1e5-992d-90d0701572ad | Product name | 9 | 20210511 |
| ccfbb2ac-2915-4b21-1d79-8a93f773e70f | Product name | 9 | 20200714 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0527-8111-37 | Dexmethylphenidate HydrochlorideExtended-Release | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 10 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0527-8111 | DEXMETHYLPHENIDATE HYDROCHLORIDE EXTENDED-RELEASE (DEXMETHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [LANNETT COMPANY, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250110_edad7c67-a872-41ad-a8bd-169278693cc2.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 899439 | dexmethylphenidate HCl 10 MG 24HR Extended Release Oral Capsule | PSN | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899461 | dexmethylphenidate HCl 15 MG 24HR Extended Release Oral Capsule | PSN | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899485 | dexmethylphenidate HCl 20 MG 24HR Extended Release Oral Capsule | PSN | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 1101926 | dexmethylphenidate HCl 25 MG 24HR Extended Release Oral Capsule | PSN | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899495 | dexmethylphenidate HCl 30 MG 24HR Extended Release Oral Capsule | PSN | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 1101932 | dexmethylphenidate HCl 35 MG 24HR Extended Release Oral Capsule | PSN | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 1006608 | dexmethylphenidate HCl 40 MG 24HR Extended Release Oral Capsule | PSN | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899511 | dexmethylphenidate HCl 5 MG 24HR Extended Release Oral Capsule | PSN | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899439 | 24 HR dexmethylphenidate hydrochloride 10 MG Extended Release Oral Capsule | SCD | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899461 | 24 HR dexmethylphenidate hydrochloride 15 MG Extended Release Oral Capsule | SCD | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899485 | 24 HR dexmethylphenidate hydrochloride 20 MG Extended Release Oral Capsule | SCD | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 1101926 | 24 HR dexmethylphenidate hydrochloride 25 MG Extended Release Oral Capsule | SCD | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899495 | 24 HR dexmethylphenidate hydrochloride 30 MG Extended Release Oral Capsule | SCD | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 1101932 | 24 HR dexmethylphenidate hydrochloride 35 MG Extended Release Oral Capsule | SCD | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 1006608 | 24 HR dexmethylphenidate hydrochloride 40 MG Extended Release Oral Capsule | SCD | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899511 | 24 HR dexmethylphenidate hydrochloride 5 MG Extended Release Oral Capsule | SCD | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899439 | dexmethylphenidate hydrochloride 10 MG 24 HR Extended Release Oral Capsule | SY | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899461 | dexmethylphenidate hydrochloride 15 MG 24 HR Extended Release Oral Capsule | SY | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899485 | dexmethylphenidate hydrochloride 20 MG 24 HR Extended Release Oral Capsule | SY | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 1101926 | dexmethylphenidate hydrochloride 25 MG 24 HR Extended Release Oral Capsule | SY | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899495 | dexmethylphenidate hydrochloride 30 MG 24 HR Extended Release Oral Capsule | SY | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 1101932 | dexmethylphenidate hydrochloride 35 MG 24 HR Extended Release Oral Capsule | SY | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 1006608 | dexmethylphenidate hydrochloride 40 MG 24 HR Extended Release Oral Capsule | SY | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
| 899511 | dexmethylphenidate hydrochloride 5 MG 24 HR Extended Release Oral Capsule | SY | edad7c67-a872-41ad-a8bd-169278693cc2 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0527-8111-37 | 00527811137 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0527-8111-37) | 2018-10-09 | 0000-00-00 | No | No | Current |