FDA.reportPublic FDA data

Cryselle

Product NDC
0555-9049
11-digit product format
005559049
Labeler code
0555
Product ID
0555-9049_1fa9262a-8c57-4a86-b5aa-b331d1612fe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norgestrel and Ethinyl Estradiol
Dosage form
KIT
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075840
Marketing category
ANDA
Marketing start
2002-07-24
Marketing end
2027-01-31
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cryselle

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui311359, 748797, 749786, 750265

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-9049-58Cryselle6 in 1 CARTONKIT615
0555-9049-79Cryselle1 in 1 BLISTER PACKKIT115
0555-9049-79Cryselle1 in 1 POUCHKIT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9049-58EA - Each0555-9049d363784a-eb4d-4cbd-88b6-3017430508e912013-02-13
0555-9049-79EA - Each0555-904987c812cf-97ed-458d-8785-498ab7bfb13d12017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
NORGESTRELACTIVE INGREDIENT3J8Q1747Z2CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
NORGESTRELACTIVE MOIETY3J8Q1747Z2CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
NORGESTRELACTIVE INGREDIENT3J8Q1747Z2CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
NORGESTRELACTIVE MOIETY3J8Q1747Z2CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9049CRYSELLE (NORGESTREL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]14Current NDC, Legacy NDC, 3 package rows20220827_ee6be128-d494-4361-9a0d-341c0eee3587.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
750265{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28]BPCKee6be128-d494-4361-9a0d-341c0eee358715
750265{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28]BPCKfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
749786{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKee6be128-d494-4361-9a0d-341c0eee358715
749786{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
750265Cryselle 28 Day PackPSNee6be128-d494-4361-9a0d-341c0eee358715
750265Cryselle 28 Day PackPSNfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
749786eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNee6be128-d494-4361-9a0d-341c0eee358715
749786eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
748797inert 1 MG Oral TabletPSNee6be128-d494-4361-9a0d-341c0eee358715
748797inert 1 MG Oral TabletPSNfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
311359norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral TabletPSNee6be128-d494-4361-9a0d-341c0eee358715
311359norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral TabletPSNfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
311359ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral TabletSCDee6be128-d494-4361-9a0d-341c0eee358715
311359ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral TabletSCDfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
748797inert ingredients 1 MG Oral TabletSCDee6be128-d494-4361-9a0d-341c0eee358715
748797inert ingredients 1 MG Oral TabletSCDfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
750265Cryselle 28 Day PackSYee6be128-d494-4361-9a0d-341c0eee358715
750265Cryselle 28 Day PackSYfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
311359ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral TabletSYee6be128-d494-4361-9a0d-341c0eee358715
311359ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral TabletSYfcf4f8ea-1eb3-4a43-87d2-16f93e90444315
750265{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28]BPCK9ef8ffe1-5cba-47dc-a405-dd523d76abb53
749786{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK9ef8ffe1-5cba-47dc-a405-dd523d76abb53
750265Cryselle 28 Day PackPSN9ef8ffe1-5cba-47dc-a405-dd523d76abb53
749786eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN9ef8ffe1-5cba-47dc-a405-dd523d76abb53
748797inert 1 MG Oral TabletPSN9ef8ffe1-5cba-47dc-a405-dd523d76abb53
311359norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral TabletPSN9ef8ffe1-5cba-47dc-a405-dd523d76abb53
311359ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral TabletSCD9ef8ffe1-5cba-47dc-a405-dd523d76abb53
748797inert ingredients 1 MG Oral TabletSCD9ef8ffe1-5cba-47dc-a405-dd523d76abb53
750265Cryselle 28 Day PackSY9ef8ffe1-5cba-47dc-a405-dd523d76abb53
311359ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral TabletSY9ef8ffe1-5cba-47dc-a405-dd523d76abb53
750265{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28]BPCK22e5d50a-a772-4e90-82f8-b49ecdf916102
749786{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK22e5d50a-a772-4e90-82f8-b49ecdf916102
750265Cryselle 28 Day PackPSN22e5d50a-a772-4e90-82f8-b49ecdf916102
749786eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN22e5d50a-a772-4e90-82f8-b49ecdf916102
748797inert 1 MG Oral TabletPSN22e5d50a-a772-4e90-82f8-b49ecdf916102
311359norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral TabletPSN22e5d50a-a772-4e90-82f8-b49ecdf916102
311359ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral TabletSCD22e5d50a-a772-4e90-82f8-b49ecdf916102
748797inert ingredients 1 MG Oral TabletSCD22e5d50a-a772-4e90-82f8-b49ecdf916102
750265Cryselle 28 Day PackSY22e5d50a-a772-4e90-82f8-b49ecdf916102
311359ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral TabletSY22e5d50a-a772-4e90-82f8-b49ecdf916102
750265{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28]BPCKcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
750265{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Cryselle 28]BPCK9c4fac8e-8744-4378-80af-7887de955a511
749786{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
749786{21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK9c4fac8e-8744-4378-80af-7887de955a511
750265Cryselle 28 Day PackPSNcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
750265Cryselle 28 Day PackPSN9c4fac8e-8744-4378-80af-7887de955a511
749786eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
749786eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN9c4fac8e-8744-4378-80af-7887de955a511
748797inert 1 MG Oral TabletPSNcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
748797inert 1 MG Oral TabletPSN9c4fac8e-8744-4378-80af-7887de955a511
311359norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral TabletPSN9c4fac8e-8744-4378-80af-7887de955a511
311359norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral TabletPSNcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
311359ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral TabletSCD9c4fac8e-8744-4378-80af-7887de955a511
311359ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral TabletSCDcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
748797inert ingredients 1 MG Oral TabletSCDcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
748797inert ingredients 1 MG Oral TabletSCD9c4fac8e-8744-4378-80af-7887de955a511
750265Cryselle 28 Day PackSYcf19bbd6-91d1-4cbd-9fc4-5c750451f6661
750265Cryselle 28 Day PackSY9c4fac8e-8744-4378-80af-7887de955a511
311359ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral TabletSY9c4fac8e-8744-4378-80af-7887de955a511
311359ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral TabletSYcf19bbd6-91d1-4cbd-9fc4-5c750451f6661

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-9049-58005559049586 POUCH in 1 CARTON (0555-9049-58) / 1 BLISTER PACK in 1 POUCH (0555-9049-79) / 1 KIT in 1 BLISTER PACK6 pouch2002-07-242027-01-31NoNoCurrent
0555-9049-79005559049791 in 1 BLISTER PACKHistorical