Methylphenidate Hydrochloride

Product NDC: 42858-080
11-digit product format: 428580080
Labeler code: 42858
Product ID: 42858-080_dd7e2d15-d45e-41dc-9d9a-7b68c229b601
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Rhodes Pharmaceuticals LLC
Application: NDA205831
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-04-01
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205831-001	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17
N205831-002	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17
N205831-003	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17
N205831-004	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17
N205831-005	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17
N205831-006	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17
N205831-007	APTENSIO XR	METHYLPHENIDATE HYDROCHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 7 matching rows.

Application-product, TE code table
Application-product	TE code
N205831-001	AB3
N205831-002	AB3
N205831-003	AB3
N205831-004	AB3
N205831-005	AB3
N205831-006	AB3
N205831-007	AB3

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-006	APTENSIO XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N205831-007	APTENSIO XR	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-006	APTENSIO XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-007	APTENSIO XR	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-006	APTENSIO XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-007	APTENSIO XR	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-006	APTENSIO XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-007	APTENSIO XR	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-006	APTENSIO XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-007	APTENSIO XR	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 5 of 8 · 301 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205831-007	AB3	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205831-001	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205831-002	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205831-003	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205831-004	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205831-005	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205831-006	AB3	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N205831-007	AB3	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205831-001	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205831-002	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205831-003	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205831-004	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205831-005	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205831-006	AB3	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N205831-007	AB3	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205831-001	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205831-002	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205831-003	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205831-004	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205831-005	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205831-006	AB3	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N205831-007	AB3	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205831-001	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205831-002	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205831-003	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205831-004	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205831-005	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205831-006	AB3	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N205831-007	AB3	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205831-001	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205831-002	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205831-003	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205831-004	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205831-005	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205831-006	AB3	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N205831-007	AB3	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205831-001	AB3	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205831-002	AB3	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205831-003	AB3	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N205831-004	AB3	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 567 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N205831-001	10039719	2019-12-16	U-2357		2018-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	6419960	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	7083808	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	7247318	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	7438930	2019-12-16		Drug product, Delist requested	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	8580310	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	9066869	2019-12-16		Drug product	2015-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	9801823	2019-12-16		Drug product	2017-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	10039719*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	6419960*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	7083808*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	7247318*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	7438930*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	8580310*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	9066869*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-001	9801823*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	10039719	2019-12-16	U-2357		2018-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	6419960	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	7083808	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	7247318	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	7438930	2019-12-16		Drug product, Delist requested	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	8580310	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	9066869	2019-12-16		Drug product	2015-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	9801823	2019-12-16		Drug product	2017-11-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	10039719*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	6419960*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	7083808*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	7247318*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	7438930*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	8580310*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	9066869*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-002	9801823*PED	2020-06-16		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	10039719	2019-12-16	U-2357		2018-08-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	6419960	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	7083808	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	7247318	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	7438930	2019-12-16		Drug product, Delist requested	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	8580310	2019-12-16		Drug product	2015-05-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	9066869	2019-12-16		Drug product	2015-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N205831-003	9801823	2019-12-16		Drug product	2017-11-29	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Methylphenidate Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLPHENIDATE HYDROCHLORIDE	50 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
143536be-f21a-464c-bc5a-163f5c171815	Product name	2	20250626
fd4d0878-dcea-3832-288e-e3bbbbe580ff	Product name	9	20240516
435f0341-cf24-41d5-8fbf-c909821e5596	Product name	1	20230313
c9b6eabb-08d7-bb2d-e81a-06be3590b436	Product name	2	20221216
67aa32c6-44f4-50de-64dd-643e8caf420d	Product name	6	20210622
50b24f34-96fa-4f1e-b262-b0baf4a4a440	Product name	4	20210513
cf83c421-eebe-4de2-b1a2-fd96e3dbfcf8	Product name	1	20200128
166d1d2d-dd55-4fdf-82e2-b83a3c5347c1	Product name	1	20190828
343a61d5-785d-cc27-a43a-0779da054d88	Product name	3	20190828
7607489b-cd15-3103-f3b1-d4283574d250	Product name	2	20190614
407f0cce-da29-4050-a512-2cabe9e5692d	Product name	9	20190611
f7f4bf1e-7c67-46c6-8c42-9beb1a06b38e	Product name	2	20190415
190572d9-6c7b-4b40-8172-c1b5f802c20f	Product name	1	20180724
2948856e-f76e-d380-d9ed-b317efafbc98	Product name	5	20180423
c0aa09de-7aa1-4a98-8f70-62ec3c97c695	Product name	1	20170803
3317aade-2d6e-f159-9fe6-e8385a825178	Product name	3	20160829
0fe52203-83a7-4fed-a91f-8e47a22cf1d3	Product name	1	20160111

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42858-080-45	Methylphenidate Hydrochloride	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42858-080-45	EA - Each	42858-080	b4a60c75-ea39-4d43-acc9-f433ee346c88	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42858-080	METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 1 package rows	20231108_f7a7ffd1-bc30-4db8-8391-dddf76acd639.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE	23655-65-4	METHYLPHENIDATE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1806200	methylphenidate HCl 10 MG 40/60 Release 24HR Extended Release Oral Capsule	PSN	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1648183	methylphenidate HCl 15 MG 40/60 Release 24HR Extended Release Oral Capsule	PSN	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806202	methylphenidate HCl 20 MG 40/60 Release 24HR Extended Release Oral Capsule	PSN	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806206	methylphenidate HCl 30 MG 40/60 Release 24HR Extended Release Oral Capsule	PSN	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806210	methylphenidate HCl 40 MG 40/60 Release 24HR Extended Release Oral Capsule	PSN	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806204	methylphenidate HCl 50 MG 40/60 Release 24HR Extended Release Oral Capsule	PSN	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806208	methylphenidate HCl 60 MG 40/60 Release 24HR Extended Release Oral Capsule	PSN	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806200	40/60 Release 24 HR methylphenidate hydrochloride 10 MG Extended Release Oral Capsule	SCD	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1648183	40/60 Release 24 HR methylphenidate hydrochloride 15 MG Extended Release Oral Capsule	SCD	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806202	40/60 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule	SCD	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806206	40/60 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule	SCD	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806210	40/60 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule	SCD	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806204	40/60 Release 24 HR methylphenidate hydrochloride 50 MG Extended Release Oral Capsule	SCD	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806208	40/60 Release 24 HR methylphenidate hydrochloride 60 MG Extended Release Oral Capsule	SCD	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806200	methylphenidate HCl 10 MG 40/60 Release 24HR Extended Release Oral Capsule	SY	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1648183	methylphenidate HCl 15 MG 40/60 Release 24HR Extended Release Oral Capsule	SY	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806202	methylphenidate HCl 20 MG 40/60 Release 24HR Extended Release Oral Capsule	SY	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806206	methylphenidate HCl 30 MG 40/60 Release 24HR Extended Release Oral Capsule	SY	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806210	methylphenidate HCl 40 MG 40/60 Release 24HR Extended Release Oral Capsule	SY	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806204	methylphenidate HCl 50 MG 40/60 Release 24HR Extended Release Oral Capsule	SY	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8
1806208	methylphenidate HCl 60 MG 40/60 Release 24HR Extended Release Oral Capsule	SY	f7a7ffd1-bc30-4db8-8391-dddf76acd639	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42858-080-45	42858008045	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-080-45)	2020-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate Hydrochloride	Rhodes Pharmaceuticals LLC \| Patheon Manufacturing Services LLC \| Knoa Pharmaceuticals LLC	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	9