APTENSIO XR
- Product NDC
- 42858-406
- 11-digit product format
- 428580406
- Labeler code
- 42858
- Product ID
- 42858-406_9468380f-2590-4c7a-9451-81776fa2cfaf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- (methylphenidate hydrochloride)
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rhodes Pharmaceuticals L.P.
- Application
- NDA205831
- Marketing category
- NDA
- Marketing start
- 2015-04-17
- Marketing end
- 0000-00-00
- Substance
- METHYLPHENIDATE HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| METHYLPHENIDATE HYDROCHLORIDE | ACTIVE INGREDIENT | 4B3SC438HI | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| METHYLPHENIDATE | ACTIVE MOIETY | 207ZZ9QZ49 | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| AMMONIO METHACRYLATE COPOLYMER TYPE B | INACTIVE INGREDIENT | 161H3B14U2 | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| TRIETHYL CITRATE | INACTIVE INGREDIENT | 8Z96QXD6UM | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | APTENSIO XR ((METHYLPHENIDATE HYDROCHLORIDE)) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42858-406 | APTENSIO XR (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.] | 13 | Legacy NDC | 20240410_5adedc01-ebf0-11e3-ac10-0800200c9a66.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42858-406-45 | 42858040645 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-406-45) | 2015-04-17 | 0000-00-00 | No | No | Current |