Home NDC 0009-3359-01 Prepidil
Product NDC 0009-3359
Requested package NDC 0009-3359-01
11-digit product format 000093359
Labeler code 0009
Product ID 0009-3359_e72f678f-ff11-47d7-94ea-186113ec3fbd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name dinoprostone
Dosage form GEL
Route VAGINAL
Labeler Pharmacia & Upjohn Company LLC
Application NDA019617
Marketing category NDA
Marketing start 1992-12-09
Substance DINOPROSTONE
Active strength .5 mg/3g
Pharmacologic classes Prostaglandin Analog [EPC], Prostaglandins [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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0009-3359 0009-3359-01 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0009-3359 0009-3359-01 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019617-001 PREPIDIL DINOPROSTONE 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09
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 2 · 41 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 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019617-001 PREPIDIL 0.5MG/3GM GEL / ENDOCERVICAL RLD, RS 1992-12-09 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Prepidil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DINOPROSTONE .5 mg/3g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K7Q1JQR04M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 208397 Internal RxNorm lookup 309922 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0009-3359 PREPIDIL (DINOPROSTONE) GEL [PHARMACIA & UPJOHN COMPANY LLC] 22 Current NDC, Legacy NDC 20250406_ab03de5b-782c-4f81-a8dc-7ef9969dd0cf.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 · 1 matching rows.
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 0009-3359-01 00009335901 1 SYRINGE in 1 CARTON (0009-3359-01) / 3 g in 1 SYRINGE 1 syringe 2019-12-11 0000-00-00 No No Current