Home NDC 66336-608 misoprostol
Product NDC 66336-608
11-digit product format 663360608
Labeler code 66336
Product ID 66336-608_15395dfd-3685-45ef-bbcb-13f95dcedf4d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MISOPROSTOL
Dosage form TABLET
Route ORAL
Labeler Dispensing Solutions, Inc.
Application NDA019268
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2009-12-27
Marketing end 0000-00-00
Substance MISOPROSTOL
Active strength 200 ug/1
Pharmacologic classes Prostaglandin E1 Analog [EPC],Prostaglandins E, Synthetic [CS]
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 · 44 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 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 66336-608-60 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 66336-608-60 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 66336-608-60 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 66336-608-60 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 66336-608-60 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 66336-608-60 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 66336-608-60 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 66336-608-60 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 66336-608-60 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 66336-608-60 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 66336-608-60 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 66336-608-60 557ba5c1ecfa…9c80585c8c6e…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 66336-608-60 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 66336-608-60 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 66336-608-60 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 66336-608-60 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 66336-608-60 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 66336-608-60 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 66336-608-60 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 66336-608-60 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 66336-608-60 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 66336-608-60 110d247fa046…a55b01930146…
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 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 · 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 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…2021-12-28 21:50 UTC 2021-12 N019268-001 CYTOTEC 0.2MG TABLET / ORAL RLD, RS 1988-12-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019268-003 CYTOTEC 0.1MG TABLET / ORAL RLD 1990-09-21 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
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 66336-608-60 misoprostol 60 in 1 BOTTLE TABLET 60 2
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66336-608 MISOPROSTOL TABLET [DISPENSING SOLUTIONS, INC.] 2 Legacy NDC, 1 package rows 20130730_1f81237e-2cf7-4c85-a054-daffe5bb1c68.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 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 Status 66336-608-60 66336060860 60 in 1 BOTTLE Historical