Methylphenidate Hydrochloride

Product NDC: 42858-077
11-digit product format: 428580077
Labeler code: 42858
Product ID: 42858-077_1b9cf2a8-126e-4302-881b-88a699bbdcf5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Rhodes Pharmaceuticals
Application: NDA205831
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2020-04-01
Substance: METHYLPHENIDATE HYDROCHLORIDE
Active strength: 20 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 294 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
2026-08-18 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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-006	APTENSIO XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-007	APTENSIO XR	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD, RS	2015-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-001	APTENSIO XR	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-002	APTENSIO XR	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-003	APTENSIO XR	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-004	APTENSIO XR	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-005	APTENSIO XR	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB3	RLD	2015-04-17	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 8 · 294 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N205831-001	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-002	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-003	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-004	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-005	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-006	AB3	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205831-007	AB3	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205831-001	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-002	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-003	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-004	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-005	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-006	AB3	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205831-007	AB3	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-001	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-002	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-003	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-004	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-005	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-006	AB3	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205831-007	AB3	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205831-001	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-002	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-003	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-004	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-005	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-006	AB3	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205831-007	AB3	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-001	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-002	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-003	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-004	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-005	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-006	AB3	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205831-007	AB3	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-001	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-002	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-003	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-004	AB3	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205831-005	AB3	1	`b8a1b40f171c…`

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…`

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	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4B3SC438HI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1648183	Internal RxNorm lookup
1806200	Internal RxNorm lookup
1806202	Internal RxNorm lookup
1806204	Internal RxNorm lookup
1806206	Internal RxNorm lookup
1806208	Internal RxNorm lookup
1806210	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f7a7ffd1-bc30-4db8-8391-dddf76acd639	Available on FDA.report

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
42858-077-45	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
42858-077-45	EA - Each	42858-077	680f35ae-9110-461c-895a-7363817091eb	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42858-077	METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [RHODES PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 1 package rows	20231108_f7a7ffd1-bc30-4db8-8391-dddf76acd639.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Rhodes Pharmaceuticals LLC	f7a7ffd1-bc30-4db8-8391-dddf76acd639	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205831 application number: NDA205831 ndc (product): 42858-077

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
42858-077-45	42858007745	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42858-077-45)	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	8