Home NDC 0023-6150 Crinone
Product NDC 0023-6150
11-digit product format 000236150
Labeler code 0023
Product ID 0023-6150_ab1523af-0bbb-4231-a12c-ac52e3ec91cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name progesterone
Dosage form GEL
Route VAGINAL
Labeler Allergan, Inc.
Application NDA020701
Marketing category NDA
Marketing start 1997-05-13
Substance PROGESTERONE
Active strength 45 mg/1.125g
Pharmacologic classes Progesterone [CS], Progesterone [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 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…
Additional Listing Data#
Finished product Yes
Brand name base Crinone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PROGESTERONE 45 mg/1.125g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4G7DS2Q64Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 153579 Internal RxNorm lookup 153580 Internal RxNorm lookup 312643 Internal RxNorm lookup 312645 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 0023-6150-04 Crinone 6 in 1 CARTON GEL 6 11 0023-6150-04 Crinone 1.125 g in 1 APPLICATOR GEL 1.125 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0023-6150 CRINONE (PROGESTERONE) GEL [ALLERGAN, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20241213_75e97aa1-daa4-45f9-b2e2-1a371302914e.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 0023-6150-04 00023615004 6 APPLICATOR in 1 CARTON (0023-6150-04) / 1.125 g in 1 APPLICATOR 6 applicator 1997-05-13 2027-04-01 No No Current