Home NDC 43393-024 Misoprostol
Product NDC 43393-024
11-digit product format 433930024
Labeler code 43393
Product ID 43393-024_28a4139f-35d2-8ea3-e063-6394a90a0812
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Misoprostol
Dosage form TABLET
Route ORAL
Labeler GenBioPro, Inc.
Application ANDA210201
Marketing category ANDA
Marketing start 2024-09-30
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 A210201-001 MISOPROSTOL MISOPROSTOL 0.1MG TABLET / ORAL AB 2019-07-02 A210201-002 MISOPROSTOL MISOPROSTOL 0.2MG TABLET / ORAL AB 2019-07-02
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 3 · 84 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 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2019-07-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2019-07-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2019-07-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2019-07-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2019-07-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2019-07-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2019-07-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2019-07-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2019-07-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2019-07-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2019-07-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2019-07-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2019-07-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2019-07-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2019-07-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2019-07-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL 2019-07-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL 2019-07-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2019-07-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2019-07-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL 2019-07-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL 2019-07-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL 2019-07-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL 2019-07-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL 2019-07-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL 2019-07-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL 2019-07-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL 2019-07-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL 2019-07-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL 2019-07-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL 2019-07-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL 2019-07-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL 2019-07-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL 2019-07-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL 2019-07-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL 2019-07-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2019-07-02 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2019-07-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210201-001 MISOPROSTOL 0.1MG TABLET / ORAL 2019-07-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210201-002 MISOPROSTOL 0.2MG TABLET / ORAL 2019-07-02 bb7c543d1eb4…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Misoprostol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MISOPROSTOL 200 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0E43V0BB57 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 317128 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 43393-024-04 Misoprostol 4 in 1 BOTTLE TABLET 4 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43393-024 MISOPROSTOL TABLET [GENBIOPRO, INC.] 1 Current NDC, 1 package rows 20241211_28a4138c-f302-5109-e063-6394a90a94fa.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Misoprostol MISOPROSTOL GenBioPro, Inc. 21e20753-4a67-ce4e-e063-6394a90aa598 2026-06-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210201 application number: ANDA210201 Misoprostol MISOPROSTOL AvPAK 2396e9c0-3742-69cf-e063-6394a90adb13 2026-01-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210201 application number: ANDA210201 Misoprostol MISOPROSTOL GenBioPro, Inc. 28a4138c-f302-5109-e063-6394a90a94fa 2024-12-09 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 210201 application number: ANDA210201 ndc (product): 43393-024
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43393-024-04 43393002404 4 TABLET in 1 BOTTLE (43393-024-04) 4 tablet 2024-12-16 No No Current