FDA.reportPublic FDA data

TriNessa

Product NDC
52544-248
11-digit product format
525440248
Labeler code
52544
Product ID
52544-248_f019d53a-7ebe-11e8-b095-81fb9d46d017
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norgestimate and ethinyl estradiol
Dosage form
KIT
Labeler
Actavis Pharma, Inc
Application
NDA019653
Marketing category
NDA
Marketing start
2003-02-11
Marketing end
2020-04-30
Active strength
0
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11Product name420250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
1a545a57-aed5-4b6e-b1f9-a93c26d50effProduct name120230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9Product name820200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
60ff9adc-7870-42ca-8836-514bd9732fa8Product name420181220
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
2d386545-84d1-e1e9-1402-7fc8962353e8Product name220170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8Product name420170608
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52544-248-28EA - Each52544-2480e779339-d6a6-469c-952f-e3be9182894b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
ethinyl estradiolACTIVE INGREDIENT423D2T571UTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
norgestimateACTIVE INGREDIENTC291HFX4DYTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
ethinyl estradiolACTIVE MOIETY423D2T571UTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
norgestimateACTIVE MOIETYC291HFX4DYTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
NORGESTIMATEACTIVE MOIETYC291HFX4DYTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933TRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
FD&C BLUE No. 2INACTIVE INGREDIENTL06K8R7DQKTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ATRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTRINESSA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
751905{7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Trinessa 28 Day]BPCK643b9e90-2bfc-411d-89cc-344add0e42052
749784{7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK643b9e90-2bfc-411d-89cc-344add0e42052
749784Eth estra-Norgestim 0.035-0.18 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.215 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.25 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN643b9e90-2bfc-411d-89cc-344add0e42052
748797inert 1 MG Oral TabletPSN643b9e90-2bfc-411d-89cc-344add0e42052
406396norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral TabletPSN643b9e90-2bfc-411d-89cc-344add0e42052
687424norgestimate 0.215 MG / ethinyl estradiol 0.035 MG Oral TabletPSN643b9e90-2bfc-411d-89cc-344add0e42052
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN643b9e90-2bfc-411d-89cc-344add0e42052
751905TriNessa 28 Day PackPSN643b9e90-2bfc-411d-89cc-344add0e42052
406396ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral TabletSCD643b9e90-2bfc-411d-89cc-344add0e42052
687424ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral TabletSCD643b9e90-2bfc-411d-89cc-344add0e42052
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD643b9e90-2bfc-411d-89cc-344add0e42052
748797inert ingredients 1 MG Oral TabletSCD643b9e90-2bfc-411d-89cc-344add0e42052
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY643b9e90-2bfc-411d-89cc-344add0e42052
751905Trinessa 28 Day PackSY643b9e90-2bfc-411d-89cc-344add0e42052
751905{7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Trinessa 28 Day]BPCK9599335c-4a8f-435d-b96c-27d5e5e34c391
751905{7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Trinessa 28 Day]BPCK69e66f08-be0b-4120-9a30-333b34ad35071
749784{7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK9599335c-4a8f-435d-b96c-27d5e5e34c391
749784{7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK69e66f08-be0b-4120-9a30-333b34ad35071
749784Eth estra-Norgestim 0.035-0.18 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.215 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.25 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN9599335c-4a8f-435d-b96c-27d5e5e34c391
749784Eth estra-Norgestim 0.035-0.18 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.215 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.25 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN69e66f08-be0b-4120-9a30-333b34ad35071
748797inert 1 MG Oral TabletPSN69e66f08-be0b-4120-9a30-333b34ad35071
748797inert 1 MG Oral TabletPSN9599335c-4a8f-435d-b96c-27d5e5e34c391
406396norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral TabletPSN69e66f08-be0b-4120-9a30-333b34ad35071
406396norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral TabletPSN9599335c-4a8f-435d-b96c-27d5e5e34c391
687424norgestimate 0.215 MG / ethinyl estradiol 0.035 MG Oral TabletPSN9599335c-4a8f-435d-b96c-27d5e5e34c391
687424norgestimate 0.215 MG / ethinyl estradiol 0.035 MG Oral TabletPSN69e66f08-be0b-4120-9a30-333b34ad35071
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN69e66f08-be0b-4120-9a30-333b34ad35071
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN9599335c-4a8f-435d-b96c-27d5e5e34c391
751905TriNessa 28 Day PackPSN9599335c-4a8f-435d-b96c-27d5e5e34c391
751905TriNessa 28 Day PackPSN69e66f08-be0b-4120-9a30-333b34ad35071
406396ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral TabletSCD69e66f08-be0b-4120-9a30-333b34ad35071
406396ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral TabletSCD9599335c-4a8f-435d-b96c-27d5e5e34c391
687424ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral TabletSCD9599335c-4a8f-435d-b96c-27d5e5e34c391
687424ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral TabletSCD69e66f08-be0b-4120-9a30-333b34ad35071
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD9599335c-4a8f-435d-b96c-27d5e5e34c391
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD69e66f08-be0b-4120-9a30-333b34ad35071
748797inert ingredients 1 MG Oral TabletSCD9599335c-4a8f-435d-b96c-27d5e5e34c391
748797inert ingredients 1 MG Oral TabletSCD69e66f08-be0b-4120-9a30-333b34ad35071
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY9599335c-4a8f-435d-b96c-27d5e5e34c391
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY69e66f08-be0b-4120-9a30-333b34ad35071
751905Trinessa 28 Day PackSY9599335c-4a8f-435d-b96c-27d5e5e34c391
751905Trinessa 28 Day PackSY69e66f08-be0b-4120-9a30-333b34ad35071