FDA.reportPublic FDA data

Aviane

Product NDC
0555-9045
11-digit product format
005559045
Labeler code
0555
Product ID
0555-9045_78285da7-bc34-478b-8393-c944dc5a1e02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levonorgestrel and Ethinyl Estradiol
Dosage form
KIT
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA075796
Marketing category
ANDA
Marketing start
2001-04-02
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aviane
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui242297, 748797, 748868, 750268

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
f713a022-3e1c-4035-bc91-62131bc80b42Product name220190125
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
741e98f2-ac6c-4d80-9ca8-c663c171ba1dProduct name120161121
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
cc765024-f257-4c67-b780-c356aadd6980Product name320150902
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
5a9b579b-8431-5b3a-2ba4-86556704f873Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d03a75af-b11b-673b-268b-318050d0b3bdProduct name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
e5ccd419-1745-560a-1e25-c6e3941c710aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-9045-58Aviane6 in 1 CARTONKIT615
0555-9045-79Aviane1 in 1 BLISTER PACKKIT115
0555-9045-79Aviane1 in 1 POUCHKIT115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-9045-58EA - Each0555-9045067451b4-f69c-4330-ab48-64e075147c4f12012-07-24
0555-9045-79EA - Each0555-904526a3912e-fc99-4799-97b8-b0074001171a12017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.]3
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UAVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWAVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UAVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWAVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AAVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-9045AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 3 package rows20240829_8f88b17a-5d0e-448a-8a60-f49c28ba6dfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
750268{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Aviane 28]BPCK8f88b17a-5d0e-448a-8a60-f49c28ba6dfb15
748868{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK8f88b17a-5d0e-448a-8a60-f49c28ba6dfb15
750268Aviane 28 Day PackPSN8f88b17a-5d0e-448a-8a60-f49c28ba6dfb15
748868Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN8f88b17a-5d0e-448a-8a60-f49c28ba6dfb15
748797inert 1 MG Oral TabletPSN8f88b17a-5d0e-448a-8a60-f49c28ba6dfb15
242297levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral TabletPSN8f88b17a-5d0e-448a-8a60-f49c28ba6dfb15
242297ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral TabletSCD8f88b17a-5d0e-448a-8a60-f49c28ba6dfb15
748797inert ingredients 1 MG Oral TabletSCD8f88b17a-5d0e-448a-8a60-f49c28ba6dfb15
750268Aviane 28 Day PackSY8f88b17a-5d0e-448a-8a60-f49c28ba6dfb15
750268{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Aviane 28]BPCK411e6e51-b435-4f86-b39f-3377f009b0e95
748868{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK411e6e51-b435-4f86-b39f-3377f009b0e95
750268Aviane 28 Day PackPSN411e6e51-b435-4f86-b39f-3377f009b0e95
748868Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN411e6e51-b435-4f86-b39f-3377f009b0e95
748797inert 1 MG Oral TabletPSN411e6e51-b435-4f86-b39f-3377f009b0e95
242297levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral TabletPSN411e6e51-b435-4f86-b39f-3377f009b0e95
242297ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral TabletSCD411e6e51-b435-4f86-b39f-3377f009b0e95
748797inert ingredients 1 MG Oral TabletSCD411e6e51-b435-4f86-b39f-3377f009b0e95
750268Aviane 28 Day PackSY411e6e51-b435-4f86-b39f-3377f009b0e95
750268{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Aviane 28]BPCK82fe374a-6b63-4be6-bc0b-0e0cfdd8e1f51
750268{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Aviane 28]BPCK9e8e429c-1960-4acd-8bc5-5002d4c6a6ac1
748868{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK9e8e429c-1960-4acd-8bc5-5002d4c6a6ac1
748868{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK82fe374a-6b63-4be6-bc0b-0e0cfdd8e1f51
750268Aviane 28 Day PackPSN82fe374a-6b63-4be6-bc0b-0e0cfdd8e1f51
750268Aviane 28 Day PackPSN9e8e429c-1960-4acd-8bc5-5002d4c6a6ac1
748868Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN82fe374a-6b63-4be6-bc0b-0e0cfdd8e1f51
748868Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN9e8e429c-1960-4acd-8bc5-5002d4c6a6ac1
748797inert 1 MG Oral TabletPSN82fe374a-6b63-4be6-bc0b-0e0cfdd8e1f51
748797inert 1 MG Oral TabletPSN9e8e429c-1960-4acd-8bc5-5002d4c6a6ac1
242297levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral TabletPSN9e8e429c-1960-4acd-8bc5-5002d4c6a6ac1
242297levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral TabletPSN82fe374a-6b63-4be6-bc0b-0e0cfdd8e1f51
242297ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral TabletSCD9e8e429c-1960-4acd-8bc5-5002d4c6a6ac1
242297ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral TabletSCD82fe374a-6b63-4be6-bc0b-0e0cfdd8e1f51
748797inert ingredients 1 MG Oral TabletSCD82fe374a-6b63-4be6-bc0b-0e0cfdd8e1f51
748797inert ingredients 1 MG Oral TabletSCD9e8e429c-1960-4acd-8bc5-5002d4c6a6ac1
750268Aviane 28 Day PackSY9e8e429c-1960-4acd-8bc5-5002d4c6a6ac1
750268Aviane 28 Day PackSY82fe374a-6b63-4be6-bc0b-0e0cfdd8e1f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-9045-58005559045586 POUCH in 1 CARTON (0555-9045-58) / 1 BLISTER PACK in 1 POUCH (0555-9045-79) / 1 KIT in 1 BLISTER PACK6 pouch2001-04-020000-00-00NoNoCurrent
0555-9045-79005559045791 in 1 BLISTER PACKHistorical