Home NDC 62135-321-18 Methyldopa
Product NDC 62135-321
Requested package NDC 62135-321-18
11-digit product format 621350321
Labeler code 62135
Product ID 62135-321_31442b54-cca3-2834-e063-6294a90aaccc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methyldopa
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chartwell RX, LLC
Application NDA018934
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1984-06-29
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 N018934-001 METHYLDOPA METHYLDOPA 250MG TABLET / ORAL 1984-06-29 N018934-002 METHYLDOPA METHYLDOPA 500MG TABLET / ORAL 1984-06-29
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 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018934-001 METHYLDOPA 250MG TABLET / ORAL 1984-06-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N018934-002 METHYLDOPA 500MG TABLET / ORAL 1984-06-29 74a2ff9319b5…
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-321-18 Methyldopa 180 in 1 BOTTLE TABLET, FILM COATED 180 3 62135-321-90 Methyldopa 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-321 METHYLDOPA TABLET, FILM COATED [CHARTWELL RX, LLC] 3 Current NDC, Legacy NDC, 2 package rows 20250328_e1114a58-9ab5-486e-85ed-360365b06396.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 62135-321-18 62135032118 180 TABLET, FILM COATED in 1 BOTTLE (62135-321-18) 2022-11-22 0000-00-00 No No Current