Methylphenidate Hydrochloride
- Product NDC
- 43386-573
- 11-digit product format
- 433860573
- Labeler code
- 43386
- Product ID
- 43386-573_ac26e6b6-2be0-458d-8acc-d963bcca13a5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Methylphenidate Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA207884
- Marketing category
- ANDA
- Marketing start
- 2016-01-20
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 5 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
- Methylphenidate Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHYLPHENIDATE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4B3SC438HI |
| Rxcui | 1091150, 1091392, 1091497 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-573-01 | Methylphenidate Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
| 43386-573-03 | Methylphenidate Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 43386-573-05 | Methylphenidate Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-573 | METHYLPHENIDATE HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS,INC.] | 8 | Current NDC, Legacy NDC, 3 package rows | 20240322_ec8a8896-077d-4dee-9e10-97172512c5ed.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 |
|---|
| 43386-573-01 | 43386057301 | 100 TABLET in 1 BOTTLE (43386-573-01) | 100 tablet | 2016-01-20 | 0000-00-00 | No | No | Current |
| 43386-573-03 | 43386057303 | 30 in 1 BOTTLE | | | | | | Historical |
| 43386-573-05 | 43386057305 | 500 TABLET in 1 BOTTLE (43386-573-05) | 500 tablet | 2016-01-20 | 0000-00-00 | No | No | Current |
| 43386-573-30 | 43386057330 | 30 TABLET in 1 BOTTLE (43386-573-30) | 30 tablet | 2016-01-20 | 0000-00-00 | No | No | Current |