Home NDC 71335-9631 misoprostol
Product NDC 71335-9631
11-digit product format 713359631
Labeler code 71335
Product ID 71335-9631_4629ba57-842d-45ec-8bf9-a1ed10a0a429
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MISOPROSTOL
Dosage form TABLET
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA019268
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2009-12-27
Substance MISOPROSTOL
Active strength 100 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 N019268-001 CYTOTEC MISOPROSTOL 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 N019268-003 CYTOTEC MISOPROSTOL 0.1MG TABLET / ORAL AB RLD 1990-09-21
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 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019268-001 CYTOTEC 0.2MG TABLET / ORAL RLD, RS 1988-12-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019268-003 CYTOTEC 0.1MG TABLET / ORAL RLD 1990-09-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019268-001 CYTOTEC 0.2MG TABLET / ORAL AB RLD, RS 1988-12-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019268-003 CYTOTEC 0.1MG TABLET / ORAL AB RLD 1990-09-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019268-001 CYTOTEC 0.2MG TABLET / ORAL RLD, RS 1988-12-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019268-003 CYTOTEC 0.1MG TABLET / ORAL RLD 1990-09-21 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 78 observed states.
Additional Listing Data#
Finished product Yes
Brand name base misoprostol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MISOPROSTOL 100 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 311727 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 71335-9631-1 misoprostol 28 in 1 BOTTLE TABLET 28 101 71335-9631-2 misoprostol 90 in 1 BOTTLE TABLET 90 101 71335-9631-3 misoprostol 30 in 1 BOTTLE TABLET 30 101
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-9631 MISOPROSTOL TABLET [BRYANT RANCH PREPACK] 101 Current NDC, 3 package rows 20231111_c842c35f-6a64-4ecc-95a1-41b6d056047e.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 Bryant Ranch Prepack c842c35f-6a64-4ecc-95a1-41b6d056047e 2026-06-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019268 application number: NDA019268 ndc (product): 71335-9631 Cytotec MISOPROSTOL Pfizer Laboratories Div Pfizer Inc 4ab12da7-5731-4e06-bf1c-bc3f2e711f12 2026-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019268 application number: NDA019268 misoprostol MISOPROSTOL Mylan Pharmaceuticals Inc. c4fe14fb-0a43-4c31-9cd6-29eb0d156705 2026-05-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019268 application number: NDA019268 misoprostol MISOPROSTOL Redpharm Drug 2fd197c6-05db-5011-e063-6294a90a585d 2025-12-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 019268 application number: NDA019268
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71335-9631-1 71335963101 28 TABLET in 1 BOTTLE (71335-9631-1) 28 tablet 2023-01-31 No No Current 71335-9631-2 71335963102 90 TABLET in 1 BOTTLE (71335-9631-2) 90 tablet 2023-01-31 No No Current 71335-9631-3 71335963103 30 TABLET in 1 BOTTLE (71335-9631-3) 30 tablet 2023-01-31 No No Current