Home NDC 42571-254-01 MISOPROSTOL
Product NDC 42571-254
Requested package NDC 42571-254-01
11-digit product format 425710254
Labeler code 42571
Product ID 42571-254_35016de6-7e52-0209-e063-6394a90ade8e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Misoprostol
Dosage form TABLET
Route ORAL
Labeler Micro Labs Limited
Application ANDA216872
Marketing category ANDA
Marketing start 2023-01-01
Substance MISOPROSTOL
Active strength 200 ug/1
Pharmacologic classes Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
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 42 .
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 A216872-001 MISOPROSTOL MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 A216872-002 MISOPROSTOL MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2 · 52 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 2026-08-18 06:07:40 2026-07 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216872-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2022-10-17 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216872-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2022-10-17 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42571-254-01 MISOPROSTOL 100 in 1 BOTTLE TABLET 100 2 42571-254-60 MISOPROSTOL 60 in 1 BOTTLE TABLET 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-254 MISOPROSTOL TABLET [MICRO LABS LIMITED] 2 Current NDC, Legacy NDC, 2 package rows 20250515_54d26ca3-d309-4048-8699-a04b3854ef9c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42571-254-01 42571025401 100 TABLET in 1 BOTTLE (42571-254-01) 100 tablet 2023-01-01 0000-00-00 No No Current