Methyldopa

Product NDC: 0378-0421
Requested package NDC: 0378-0421-01
11-digit product format: 003780421
Labeler code: 0378
Product ID: 0378-0421_5f985660-415a-40e4-a386-a513a1e7b80e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methyldopa
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA070076
Marketing category: ANDA
Marketing start: 1985-04-18
Marketing end: 0000-00-00
Substance: METHYLDOPA
Active strength: 500 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0378-0421	0378-0421-01	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A070076-001	METHYLDOPA	METHYLDOPA	500MG	TABLET / ORAL		RS	1985-04-18
A070076-002	METHYLDOPA	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18

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 3 · 86 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	A070076-001	METHYLDOPA	500MG	TABLET / ORAL		RS	1985-04-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A070076-001	METHYLDOPA	500MG	TABLET / ORAL		RS	1985-04-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A070076-001	METHYLDOPA	500MG	TABLET / ORAL		RS	1985-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070076-001	METHYLDOPA	500MG	TABLET / ORAL		RS	1985-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A070076-001	METHYLDOPA	500MG	TABLET / ORAL		RS	1985-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070076-001	METHYLDOPA	500MG	TABLET / ORAL		RS	1985-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070076-001	METHYLDOPA	500MG	TABLET / ORAL		RS	1985-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070076-001	METHYLDOPA	500MG	TABLET / ORAL		RS	1985-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070076-001	METHYLDOPA	500MG	TABLET / ORAL		RS	1985-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070076-001	METHYLDOPA	500MG	TABLET / ORAL			1985-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070076-001	METHYLDOPA	500MG	TABLET / ORAL			1985-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A070076-001	METHYLDOPA	500MG	TABLET / ORAL			1985-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070076-001	METHYLDOPA	500MG	TABLET / ORAL			1985-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070076-001	METHYLDOPA	500MG	TABLET / ORAL			1985-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070076-001	METHYLDOPA	500MG	TABLET / ORAL			1985-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A070076-001	METHYLDOPA	500MG	TABLET / ORAL			1985-04-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070076-001	METHYLDOPA	500MG	TABLET / ORAL			1985-04-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A070076-001	METHYLDOPA	500MG	TABLET / ORAL			1985-04-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A070076-001	METHYLDOPA	500MG	TABLET / ORAL			1985-04-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A070076-002	METHYLDOPA	250MG	TABLET / ORAL			1985-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A070076-001	METHYLDOPA	500MG	TABLET / ORAL	AB	RS	1985-04-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070076-002	METHYLDOPA	250MG	TABLET / ORAL	AB		1985-04-18	`74a2ff9319b5…`

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	A070076-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A070076-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070076-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A070076-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A070076-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A070076-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A070076-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A070076-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A070076-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A070076-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A070076-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A070076-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A070076-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A070076-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A070076-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A070076-002	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0421-01	EA - Each	0378-0421	70d84416-6564-4018-ae5a-557e157e329e	1	2012-07-24
0378-0421-05	EA - Each	0378-0421	09c47679-0b2e-443a-9963-8982af9229c2	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHYLDOPA	ACTIVE INGREDIENT	56LH93261Y	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
METHYLDOPA ANHYDROUS	ACTIVE MOIETY	M4R0H12F6M	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	METHYLDOPA TABLET [MYLAN PHARMACEUTICALS INC.]	8
METHYLDOPA	ACTIVE INGREDIENT	56LH93261Y	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
METHYLDOPA ANHYDROUS	ACTIVE MOIETY	M4R0H12F6M	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	METHYLDOPA TABLET [MYLAN INSTITUTIONAL INC.]	3

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
Methyldopa	METHYLDOPA	Rising Pharma Holdings, Inc.	9e22e1d8-04ec-4b67-92ea-b09c706f2703	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 070076 application number: ANDA070076

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
56LH93261Y	METHYLDOPA	41372-08-1	METHYLDOPA

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0421-01	00378042101	100 TABLET in 1 BOTTLE, PLASTIC (0378-0421-01)	100 tablet	1985-04-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methyldopa - Mylan Institutional Inc.	Mylan Institutional Inc.	2019-11-06	HUMAN PRESCRIPTION DRUG LABEL	8
Methyldopa - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2015-05-14	HUMAN PRESCRIPTION DRUG LABEL	10