FDA.reportPublic FDA data

Prochieve

Product NDC
55056-1601
11-digit product format
550561601
Labeler code
55056
Product ID
55056-1601_6ea8a930-2eae-435e-b13c-f2c9e9a4bf00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
progesterone
Dosage form
GEL
Route
VAGINAL
Labeler
Columbia Laboratories
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55056-1601-52019-10-21C16284748780-1956f9ecf-bd6f-621f-e053-dbdaa90a74adProchieve ® 4% Prochieve ® 8% (progesterone gel)
55056-1601-62019-10-21C16284748780-1956f9ecf-bd6f-621f-e053-dbdaa90a74adProchieve ® 4% Prochieve ® 8% (progesterone gel)
55056-1601-82019-10-21C16284748780-1956f9ecf-bd6f-621f-e053-dbdaa90a74adProchieve ® 4% Prochieve ® 8% (progesterone gel)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55056-1601-5Prochieve1.125 g in 1 APPLICATORGEL1.1251
55056-1601-5Prochieve15 in 1 CARTONGEL151
55056-1601-6Prochieve1.125 g in 1 APPLICATORGEL1.1251
55056-1601-6Prochieve6 in 1 CARTONGEL61
55056-1601-8Prochieve1.125 g in 1 APPLICATORGEL1.1251
55056-1601-8Prochieve18 in 1 CARTONGEL181

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
progesteroneACTIVE INGREDIENT4G7DS2Q64YPROCHIEVE (PROGESTERONE) GEL [COLUMBIA LABORATORIES]1
progesteroneACTIVE MOIETY4G7DS2Q64YPROCHIEVE (PROGESTERONE) GEL [COLUMBIA LABORATORIES]1
carbomer 934INACTIVE INGREDIENTZ135WT9208PROCHIEVE (PROGESTERONE) GEL [COLUMBIA LABORATORIES]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXPROCHIEVE (PROGESTERONE) GEL [COLUMBIA LABORATORIES]1
hydrogenated palm oilINACTIVE INGREDIENT257THB963HPROCHIEVE (PROGESTERONE) GEL [COLUMBIA LABORATORIES]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPPROCHIEVE (PROGESTERONE) GEL [COLUMBIA LABORATORIES]1
polycarbophilINACTIVE INGREDIENTW25LM17A4WPROCHIEVE (PROGESTERONE) GEL [COLUMBIA LABORATORIES]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IPROCHIEVE (PROGESTERONE) GEL [COLUMBIA LABORATORIES]1
sorbic acidINACTIVE INGREDIENTX045WJ989BPROCHIEVE (PROGESTERONE) GEL [COLUMBIA LABORATORIES]1
waterINACTIVE INGREDIENT059QF0KO0RPROCHIEVE (PROGESTERONE) GEL [COLUMBIA LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55056-1601PROCHIEVE (PROGESTERONE) GEL [COLUMBIA LABORATORIES]1Legacy NDC, 6 package rows20091214_9f8dc923-65d7-42ff-b718-97e7a7e87822.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404323Prochieve 4 % Vaginal GelPSN9f8dc923-65d7-42ff-b718-97e7a7e878221
351825PROCHIEVE 8 % Vaginal GelPSN9f8dc923-65d7-42ff-b718-97e7a7e878221
312643progesterone 4 % Vaginal GelPSN9f8dc923-65d7-42ff-b718-97e7a7e878221
312645progesterone 8 % Vaginal GelPSN9f8dc923-65d7-42ff-b718-97e7a7e878221
404323progesterone 0.04 MG/MG Vaginal Gel [Prochieve]SBD9f8dc923-65d7-42ff-b718-97e7a7e878221
351825progesterone 0.08 MG/MG Vaginal Gel [Prochieve]SBD9f8dc923-65d7-42ff-b718-97e7a7e878221
312643progesterone 0.04 MG/MG Vaginal GelSCD9f8dc923-65d7-42ff-b718-97e7a7e878221
312645progesterone 0.08 MG/MG Vaginal GelSCD9f8dc923-65d7-42ff-b718-97e7a7e878221
404323Prochieve 0.04 MG/MG Vaginal GelSY9f8dc923-65d7-42ff-b718-97e7a7e878221
351825Prochieve 0.08 MG/MG Vaginal GelSY9f8dc923-65d7-42ff-b718-97e7a7e878221
404323Prochieve 4 % Vaginal GelSY9f8dc923-65d7-42ff-b718-97e7a7e878221
351825Prochieve 8 % Vaginal GelSY9f8dc923-65d7-42ff-b718-97e7a7e878221
312643progesterone 4 % Vaginal GelSY9f8dc923-65d7-42ff-b718-97e7a7e878221
312645progesterone 8 % Vaginal GelSY9f8dc923-65d7-42ff-b718-97e7a7e878221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55056-1601-5550561601051.125 g in 1 APPLICATOR1.125 gHistorical
55056-1601-6550561601061.125 g in 1 APPLICATOR1.125 gHistorical
55056-1601-8550561601081.125 g in 1 APPLICATOR1.125 gHistorical