Crinone

Product NDC
0023-6151
11-digit product format
000236151
Labeler code
0023
Product ID
0023-6151_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
90 mg/1.125g
Pharmacologic classes
Progesterone [CS], Progesterone [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Crinone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROGESTERONE90 mg/1.125g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4G7DS2Q64Y
Rxcui153579, 153580, 312643, 312645

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-6151-08Crinone1.125 g in 1 APPLICATORGEL1.12511
0023-6151-08Crinone15 in 1 CARTONGEL1511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-6151-08GM - Gram0023-61510d1ef33d-6f0c-4018-8f7a-3959e3d81a5812018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-6151CRINONE (PROGESTERONE) GEL [ALLERGAN, INC.]8Current NDC, Legacy NDC, 2 package rows20241213_75e97aa1-daa4-45f9-b2e2-1a371302914e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
153579Crinone 4 % Vaginal GelPSN75e97aa1-daa4-45f9-b2e2-1a371302914e11
153580Crinone 8 % Vaginal GelPSN75e97aa1-daa4-45f9-b2e2-1a371302914e11
312643progesterone 4 % Vaginal GelPSN75e97aa1-daa4-45f9-b2e2-1a371302914e11
312645progesterone 8 % Vaginal GelPSN75e97aa1-daa4-45f9-b2e2-1a371302914e11
153579progesterone 0.04 MG/MG Vaginal Gel [Crinone]SBD75e97aa1-daa4-45f9-b2e2-1a371302914e11
153580progesterone 0.08 MG/MG Vaginal Gel [Crinone]SBD75e97aa1-daa4-45f9-b2e2-1a371302914e11
312643progesterone 0.04 MG/MG Vaginal GelSCD75e97aa1-daa4-45f9-b2e2-1a371302914e11
312645progesterone 0.08 MG/MG Vaginal GelSCD75e97aa1-daa4-45f9-b2e2-1a371302914e11
153579Crinone 0.04 MG/MG Vaginal GelSY75e97aa1-daa4-45f9-b2e2-1a371302914e11
153580Crinone 0.08 MG/MG Vaginal GelSY75e97aa1-daa4-45f9-b2e2-1a371302914e11
153579Crinone 4 % Vaginal GelSY75e97aa1-daa4-45f9-b2e2-1a371302914e11
153580Crinone 8 % Vaginal GelSY75e97aa1-daa4-45f9-b2e2-1a371302914e11
312643progesterone 4 % Vaginal GelSY75e97aa1-daa4-45f9-b2e2-1a371302914e11
312645progesterone 8 % Vaginal GelSY75e97aa1-daa4-45f9-b2e2-1a371302914e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-6151-080002361510815 APPLICATOR in 1 CARTON (0023-6151-08) / 1.125 g in 1 APPLICATOR15 applicator1997-05-130000-00-00NoNoCurrent