Home NDC 55056-0818 Crinone
Product NDC 55056-0818
11-digit product format 550560818
Labeler code 55056
Product ID 55056-0818_f2c9bbef-22b9-413b-930d-e84fbea8247b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name progesterone
Dosage form GEL
Route VAGINAL
Labeler Columbia Laboratories, Inc.
Application NDA020701
Marketing category NDA
Marketing start 1997-05-13
Marketing end 0000-00-00
Substance PROGESTERONE
Active strength 90 mg/1.125g
Pharmacologic classes Progesterone [CS],Progesterone [EPC]
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 2 · 88 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 N020701-001 CRINONE PROGESTERONE 4% GEL / VAGINAL RLD 1997-07-31 N020701-002 CRINONE PROGESTERONE 8% GEL / VAGINAL RLD, RS 1997-07-31
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 N020701-001 CRINONE 4% GEL / VAGINAL RLD 1997-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020701-001 CRINONE 4% GEL / VAGINAL RLD, RS 1997-07-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020701-002 CRINONE 8% GEL / VAGINAL RLD, RS 1997-07-31 bb7c543d1eb4…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded progesterone ACTIVE INGREDIENT 4G7DS2Q64Y CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.] 2 progesterone ACTIVE MOIETY 4G7DS2Q64Y CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.] 2 carbomer 934 INACTIVE INGREDIENT Z135WT9208 CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.] 2 mineral oil INACTIVE INGREDIENT T5L8T28FGP CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.] 2 palm oil INACTIVE INGREDIENT 5QUO05548Z CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.] 2 polycarbophil INACTIVE INGREDIENT W25LM17A4W CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.] 2 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.] 2 sorbic acid INACTIVE INGREDIENT X045WJ989B CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.] 2 water INACTIVE INGREDIENT 059QF0KO0R CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55056-0818 CRINONE (PROGESTERONE) GEL [COLUMBIA LABORATORIES, INC.] 2 Legacy NDC, 6 package rows 20091214_2c8ffbd2-6b7a-42c7-b29e-e4de69dad9e6.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 Crinone PROGESTERONE Allergan, Inc. 75e97aa1-daa4-45f9-b2e2-1a371302914e 2024-05-21 Warnings, Adverse reactions Exact identifier application applno (NDA): 020701 application number: NDA020701
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 55056-0818-2 55056081802 1.125 g in 1 APPLICATOR 1.125 g Historical 55056-0818-5 55056081805 1.125 g in 1 APPLICATOR 1.125 g Historical 55056-0818-9 55056081809 2 in 1 CARTON Historical