Home NDC 54348-148 Misoprostol
Product NDC 54348-148
11-digit product format 543480148
Labeler code 54348
Product ID 54348-148_ea92d79f-b58c-2ad8-e053-2a95a90acafb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MISOPROSTOL
Dosage form TABLET
Route ORAL
Labeler PharmPak, Inc.
Application ANDA091667
Marketing category ANDA
Marketing start 2019-07-10
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 1 .
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 · 82 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 2026-02-19 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…2021-12-28 21:50 UTC 2021-12 A091667-001 MISOPROSTOL 0.1MG TABLET / ORAL BX 2012-07-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091667-002 MISOPROSTOL 0.2MG TABLET / ORAL BX 2012-07-25 782e0a99824c…
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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54348-148 MISOPROSTOL TABLET [PHARMPAK, INC.] 3 Current NDC, Legacy NDC, 16 package rows 20221011_b07b3dfc-1cb5-484c-be11-8d14c89c794f.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 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 ndc (product): 54348-148 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 54348-148-00 54348014800 1 BOTTLE in 1 BOX (54348-148-00) / 1 TABLET in 1 BOTTLE 1 bottle 2019-07-10 0000-00-00 No No Current 54348-148-01 54348014801 1 BOTTLE in 1 BOX (54348-148-01) / 1 TABLET in 1 BOTTLE 1 bottle 2019-07-10 0000-00-00 No No Current 54348-148-02 54348014802 1 BOTTLE in 1 BOX (54348-148-02) / 2 TABLET in 1 BOTTLE 1 bottle 2019-07-10 0000-00-00 No No Current 54348-148-03 54348014803 1 BOTTLE in 1 BOX (54348-148-03) / 3 TABLET in 1 BOTTLE 1 bottle 2019-07-10 0000-00-00 No No Current 54348-148-04 54348014804 1 BOTTLE in 1 BOX (54348-148-04) / 4 TABLET in 1 BOTTLE 1 bottle 2019-07-10 0000-00-00 No No Current 54348-148-06 54348014806 1 BOTTLE in 1 BOX (54348-148-06) / 6 TABLET in 1 BOTTLE 1 bottle 2019-07-10 0000-00-00 No No Current 54348-148-08 54348014808 1 BOTTLE in 1 BOX (54348-148-08) / 8 TABLET in 1 BOTTLE 1 bottle 2019-07-10 0000-00-00 No No Current 54348-148-09 54348014809 1 BOTTLE in 1 BOX (54348-148-09) / 9 TABLET in 1 BOTTLE 1 bottle 2019-07-10 0000-00-00 No No Current