Home NDC 55566-1501-1 Novarel
Product NDC 55566-1501
Requested package NDC 55566-1501-1
11-digit product format 555661501
Labeler code 55566
Product ID 55566-1501_655901b8-a886-4b78-98f8-a0739225ed7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gonadotrophin, chorionic
Dosage form KIT
Labeler Ferring Pharmaceuticals Inc.
Application BLA017016
Marketing category BLA
Marketing start 1974-01-15
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2021-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Gonadotrophin, Chorionic ACTIVE INGREDIENT 20ED16GHEB NOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.] 20 Gonadotrophin, Chorionic ACTIVE MOIETY 20ED16GHEB NOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.] 20 Mannitol INACTIVE INGREDIENT 3OWL53L36A NOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.] 20 Sodium Phosphate, Dibasic INACTIVE INGREDIENT GR686LBA74 NOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.] 20 Sodium Phosphate, Monobasic INACTIVE INGREDIENT 3980JIH2SW NOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.] 20 Water INACTIVE INGREDIENT 059QF0KO0R NOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.] 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55566-1501 NOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.] 39 Legacy NDC 20241122_ac6918ff-9dc3-40d9-8619-54b26e4bdfc8.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Novarel GONADOTROPHIN, CHORIONIC Ferring Pharmaceuticals Inc. ac6918ff-9dc3-40d9-8619-54b26e4bdfc8 2025-08-27 Warnings, Adverse reactions Exact identifier application number: BLA017016
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 017016 Novarel chorionic gonadotropin 351(a) Disc 2026-07-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55566-1501-1 55566150101 1 KIT in 1 CARTON (55566-1501-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL (55566-1700-0) 1 kit 1974-01-15 0000-00-00 No No Current