Methylphenidate Hydrochloride

Product NDC: 0093-5346
11-digit product format: 000935346
Labeler code: 0093
Product ID: 0093-5346_663ba889-95b5-45c2-af06-c90459d30d6d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methylphenidate Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA079031
Marketing category: ANDA
Marketing start: 2012-07-16
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 1.

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 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079031-001	METHYLPHENIDATE HYDROCHLORIDE	20MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079031-002	METHYLPHENIDATE HYDROCHLORIDE	30MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079031-003	METHYLPHENIDATE HYDROCHLORIDE	40MG	CAPSULE, EXTENDED RELEASE / ORAL	2012-07-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A079031-004	METHYLPHENIDATE HYDROCHLORIDE	10MG	CAPSULE, EXTENDED RELEASE / ORAL	2014-10-15	`d06236e962d9…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methylphenidate Hydrochloride
Brand name suffix: (LA)
Listing expiration: 2026-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1806177	Internal RxNorm lookup
1806179	Internal RxNorm lookup
1806183	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
034fb7cd-e183-475e-8beb-64fd88facc8f	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
0093-5346-01	Methylphenidate Hydrochloride(LA)	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-5346-01	EA - Each	0093-5346	c62ad8f1-760f-4bca-a8be-adcd6a078de2	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLPHENIDATE HYDROCHLORIDE	ACTIVE INGREDIENT	4B3SC438HI	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
METHYLPHENIDATE	ACTIVE MOIETY	207ZZ9QZ49	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
AMMONIO METHACRYLATE COPOLYMER TYPE B	INACTIVE INGREDIENT	161H3B14U2	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
HYPROMELLOSE 2208 (3 MPA.S)	INACTIVE INGREDIENT	9H4L916OBU	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
SUCROSE	INACTIVE INGREDIENT	C151H8M554	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-5346	METHYLPHENIDATE HYDROCHLORIDE (LA) (METHYLPHENIDATE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]	10	Current NDC, Legacy NDC, 1 package rows	20211119_034fb7cd-e183-475e-8beb-64fd88facc8f.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 (LA)	METHYLPHENIDATE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	034fb7cd-e183-475e-8beb-64fd88facc8f	2019-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079031 application number: ANDA079031 ndc (product): 0093-5346

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
1806177	methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral Capsule	PSN	034fb7cd-e183-475e-8beb-64fd88facc8f	10
1806179	methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral Capsule	PSN	034fb7cd-e183-475e-8beb-64fd88facc8f	10
1806183	methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral Capsule	PSN	034fb7cd-e183-475e-8beb-64fd88facc8f	10
1806177	50/50 Release 24 HR methylphenidate hydrochloride 20 MG Extended Release Oral Capsule	SCD	034fb7cd-e183-475e-8beb-64fd88facc8f	10
1806179	50/50 Release 24 HR methylphenidate hydrochloride 30 MG Extended Release Oral Capsule	SCD	034fb7cd-e183-475e-8beb-64fd88facc8f	10
1806183	50/50 Release 24 HR methylphenidate hydrochloride 40 MG Extended Release Oral Capsule	SCD	034fb7cd-e183-475e-8beb-64fd88facc8f	10
1806177	methylphenidate HCl 20 MG 50/50 Release 24HR Extended Release Oral Capsule	SY	034fb7cd-e183-475e-8beb-64fd88facc8f	10
1806179	methylphenidate HCl 30 MG 50/50 Release 24HR Extended Release Oral Capsule	SY	034fb7cd-e183-475e-8beb-64fd88facc8f	10
1806183	methylphenidate HCl 40 MG 50/50 Release 24HR Extended Release Oral Capsule	SY	034fb7cd-e183-475e-8beb-64fd88facc8f	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-5346-01	00093534601	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-5346-01)	2012-07-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methylphenidate Hydrochloride (LA)	Teva Pharmaceuticals USA, Inc.	2019-12-31	HUMAN PRESCRIPTION DRUG LABEL	10