Application 079031

Type: ANDA
Sponsor: BARR LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	No	No
002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	No	No
003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	No	No
004	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A079031-001	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13
A079031-002	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13
A079031-003	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13
A079031-004	METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15

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 4 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-02-18 07:12 UTC	2024-02	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A079031-001	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079031-002	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079031-003	AB1	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079031-004	AB1	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A079031-001	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079031-002	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079031-003	AB1	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A079031-004	AB1	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079031-001	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079031-002	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079031-003	AB1	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A079031-004	AB1	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079031-001	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079031-002	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079031-003	AB1	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A079031-004	AB1	1	`ea99ee380514…`

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 4 · 72 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Northstar Rx LLC	768bf181-d0d8-49e5-9c87-cacbb069e0b2	2026-08-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	45d33807-88b2-4b42-9c86-e5b05d7adec1	2026-08-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	18024571-4505-6d51-e063-6294a90a1972	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Aurolife Pharma, LLC	35be77db-fbe3-487e-a220-a08a11aaec28	2026-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply, Inc.	98be5c84-b348-6b8e-e053-2995a90ae4cc	2026-08-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METHYLPHENIDATE HYDROCHLORIDE generic name: METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride CD	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, LLC	e45c75dc-d381-475b-b649-a871c8a36e60	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
METADATE CD	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, LLC	29f06562-6b6a-4ca6-b62e-d08a45fb3dd4	2026-07-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, Inc.	44737c1d-fe75-409e-8a58-591696d3d7aa	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	10aa0dc0-bd0e-4927-a19a-8722d78ad67d	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate	METHYLPHENIDATE HYDROCHLORIDE	KVK-Tech, Inc.	2cf1b26b-199d-4c7f-ab64-4805a9def2cc	2026-05-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Lannett Company, Inc.	3d1f5aff-5d39-496c-b5ed-7f3c70ec641c	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Actavis Pharma, Inc.	85ef422d-af27-4126-9841-6892af1871d6	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Trigen Laboratories, LLC	c45dc1de-adfa-4b3c-a7dc-cffbc8eac74f	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Golden State Medical Supply, Inc.	22e5ddfa-7264-fbb1-e063-6394a90a6483	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	Janssen Pharmaceuticals, Inc.	1a88218c-5b18-4220-8f56-526de1a276cd	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Quillivant XR	METHYLPHENIDATE HYDROCHLORIDE	NextWave Pharmaceuticals, Inc	c2dc2109-44a6-4797-b04e-18761dd9d45a	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	cd2c1226-fa19-4734-b62d-89fea73dcb0d	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	Bryant Ranch Prepack	5a29687b-5294-4b27-a556-514b092a877d	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	KVK-TECH, INC.	1bf37f9f-29cf-4b09-9c81-eb369e35a042	2026-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE
Methylphenidate Hydrochloride	METHYLPHENIDATE HYDROCHLORIDE	American Health Packaging	f6581305-cd1e-4171-8c1b-e184c7bde033	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Methylphenidate Hydrochloride generic name: METHYLPHENIDATE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5346	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5346	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5346	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5346	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5347	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5347	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5347	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5347	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5348	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5348	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5348	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5348	Methylphenidate Hydrochloride	Methylphenidate Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current