Methyldopa

Product NDC: 64980-571
11-digit product format: 649800571
Labeler code: 64980
Product ID: 64980-571_807ace4b-b2af-44b4-9371-884d73e21601
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methyldopa
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA070076
Marketing category: ANDA
Marketing start: 2025-04-04
Substance: METHYLDOPA
Active strength: 250 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
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 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.

Additional Listing Data#

Finished product: Yes
Brand name base: Methyldopa
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYLDOPA	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
56LH93261Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197956	Internal RxNorm lookup
197958	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
9e22e1d8-04ec-4b67-92ea-b09c706f2703	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
512b4ef2-bf6c-5103-2bac-fd8ec25453ad	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64980-571-01	Methyldopa	100 in 1 BOTTLE	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-571-01	EA - Each	64980-571	81cd9776-0113-45e3-ae52-82fd8acfaab3	1	2025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64980-571	METHYLDOPA TABLET [RISING PHARMA HOLDINGS, INC.]	3	Current NDC, 1 package rows	20250406_9e22e1d8-04ec-4b67-92ea-b09c706f2703.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
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 ndc (product): 64980-571

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197956	methyldopa 250 MG Oral Tablet	PSN	9e22e1d8-04ec-4b67-92ea-b09c706f2703	3
197958	methyldopa 500 MG Oral Tablet	PSN	9e22e1d8-04ec-4b67-92ea-b09c706f2703	3
197956	methyldopa 250 MG Oral Tablet	SCD	9e22e1d8-04ec-4b67-92ea-b09c706f2703	3
197958	methyldopa 500 MG Oral Tablet	SCD	9e22e1d8-04ec-4b67-92ea-b09c706f2703	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
64980-571-01	64980057101	100 TABLET in 1 BOTTLE (64980-571-01)	100 tablet	2025-04-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METHYLDOPA TABLETS, USP 250 mg and 500 mg Rising Pharma Holdings, Inc. Rx Only	Rising Pharma Holdings, Inc. \| APPCO PHARMA LLC	2025-03-28	Human Prescription Drug Label	3