Application 202842

Type: ANDA
Sponsor: PAR PHARM INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	5MG	No	No
002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No
003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	No	No
004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	No	No
006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	35MG	No	No
008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A202842-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30
A202842-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A202842-001	AB
A202842-002	AB
A202842-003	AB
A202842-004	AB
A202842-005	AB
A202842-006	AB
A202842-007	AB
A202842-008	AB

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 9 · 336 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202842-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202842-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202842-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-001	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-002	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-003	DEXMETHYLPHENIDATE HYDROCHLORIDE	15MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-004	DEXMETHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-005	DEXMETHYLPHENIDATE HYDROCHLORIDE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-006	DEXMETHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-007	DEXMETHYLPHENIDATE HYDROCHLORIDE	35MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-008	DEXMETHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2016-11-30	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 336 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	A202842-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-006	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-007	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202842-008	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202842-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202842-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202842-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202842-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202842-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202842-008	AB	1	`fd3edfee7708…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	d9c450fa-c8c5-4ff0-a263-4a9eee6f5437	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b64f3622-b3d7-4a1e-9f1f-0ac0fe3dadfe	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b82e8d08-cc4a-40a6-85a5-07717f3cb38b	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	b7410d65-9c7f-4ffd-b957-969e2725f38f	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	9700cc3d-52e9-40e4-8595-f1c56279a2e0	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	6593b3ae-efcc-49ff-ba51-3fb5558605e5	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	06bcef7a-b321-4dd8-9bf6-5d8f8940f04a	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842 ndc (product): 63629-2176
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	a03d8819-a315-4337-ac50-530af98082b0	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842 ndc (product): 63629-2174
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	424da264-7448-4364-939f-d3ebbee1a6d7	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842 ndc (product): 63629-2173
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	d3318fec-a1bc-4e3c-86a9-3f00ec296869	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842 ndc (product): 63629-2178
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	c423a632-e8e0-44a7-a8a8-f66cec81aa64	2024-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842 ndc (product): 63629-2171
Dexmethylphenidate Hydrochloride	DEXMETHYLPHENIDATE HYDROCHLORIDE	Par Health USA, LLC	e304388e-86a6-4335-abae-0ce79c7c99c6	2024-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202842 application number: ANDA202842 ndc (product): 49884-248 ndc (product): 49884-539 ndc (product): 49884-049 ndc (product): 49884-339 ndc (product): 49884-333 ndc (product): 49884-090 ndc (product): 49884-546 ndc (product): 49884-048

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 58 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
49884-048	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-048	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-048	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-048	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-048	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-049	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-049	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-049	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-049	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-049	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-090	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-090	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-090	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-090	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-090	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-248	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-248	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-248	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-248	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-248	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-333	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-333	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-333	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-333	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-333	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-339	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-339	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-339	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-339	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-339	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-539	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-539	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-539	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-539	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-539	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-546	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-546	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-546	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-546	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
49884-546	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Par Pharmaceutical, Inc.	ANDA	Current
63629-2171	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2171	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2171	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2173	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2173	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2173	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2174	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2174	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2174	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2176	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2176	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2176	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2177	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2177	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2177	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2178	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2178	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2178	Dexmethylphenidate Hydrochloride	Dexmethylphenidate Hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46034	ORIG	2016-12-06