Home NDC 68071-4843 Misoprostol
Product NDC 68071-4843
11-digit product format 680714843
Labeler code 68071
Product ID 68071-4843_1ae170f1-2117-c3ed-e063-6294a90a6536
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Misoprostol
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application ANDA091667
Marketing category ANDA
Marketing start 2012-07-25
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 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 68071-4843-3 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 68071-4843-3 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 68071-4843-3 1332a3947898…d4bfe170f9cd…
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 A091667-001 MISOPROSTOL MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 A091667-002 MISOPROSTOL MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25
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 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL 2012-07-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL 2012-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL BX 2012-07-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL BX 2012-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL BX 2012-07-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL BX 2012-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL BX 2012-07-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL BX 2012-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL AB 2012-07-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL AB 2012-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL BX 2012-07-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL BX 2012-07-25 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-4843-3 Misoprostol 3 in 1 BOTTLE TABLET 3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-4843 MISOPROSTOL TABLET [NUCARE PHARMACEUTICALS,INC.] 3 Current NDC, Legacy NDC, 1 package rows 20240616_8642b8e4-d1bb-f12a-e053-2a91aa0a14bf.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Misoprostol MISOPROSTOL NuCare Pharmaceuticals,Inc. 8642b8e4-d1bb-f12a-e053-2a91aa0a14bf 2024-06-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091667 application number: ANDA091667 ndc (product): 68071-4843 Misoprostol MISOPROSTOL PharmPak, Inc. b07b3dfc-1cb5-484c-be11-8d14c89c794f 2022-10-08 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091667 application number: ANDA091667 Misoprostol MISOPROSTOL Lupin Pharmaceuticals,Inc. 14f73ae3-7d8d-4d10-b668-8bd5adf8032c 2020-12-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091667 application number: ANDA091667 Misoprostol MISOPROSTOL Novel Laboratories, Inc. a46d05a2-5014-40ff-8f1b-9eca1b0aff3a 2020-12-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091667 application number: ANDA091667
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 68071-4843-3 68071484303 3 TABLET in 1 BOTTLE (68071-4843-3) 3 tablet 2019-04-11 0000-00-00 No No Current