Home NDC 0555-9045 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075796-001 AVIANE-28 ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 A075796-002 AVIANE-21 ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075796-001 AB1
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075796-001 AVIANE-28 0.02MG;0.1MG TABLET / ORAL-28 AB1 2001-04-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A075796-002 AVIANE-21 0.02MG;0.1MG TABLET / ORAL-21 2001-04-30 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Aviane
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 242297 Internal RxNorm lookup 748797 Internal RxNorm lookup 748868 Internal RxNorm lookup 750268 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0555-9045-58 Aviane 6 in 1 CARTON KIT 6 15 0555-9045-79 Aviane 1 in 1 BLISTER PACK KIT 1 15 0555-9045-79 Aviane 1 in 1 POUCH KIT 1 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 LEVONORGESTREL ACTIVE INGREDIENT 5W7SIA7YZW AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 LEVONORGESTREL ACTIVE MOIETY 5W7SIA7YZW AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 POLYETHYLENE GLYCOL 4000 INACTIVE INGREDIENT 4R4HFI6D95 AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BARR LABORATORIES INC.] 3 ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 LEVONORGESTREL ACTIVE INGREDIENT 5W7SIA7YZW AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 LEVONORGESTREL ACTIVE INGREDIENT 5W7SIA7YZW AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 LEVONORGESTREL ACTIVE MOIETY 5W7SIA7YZW AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 LEVONORGESTREL ACTIVE MOIETY 5W7SIA7YZW AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AVIANE 28 DAY (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0555-9045 AVIANE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS USA, INC.] 15 Current NDC, Legacy NDC, 3 package rows 20240829_8f88b17a-5d0e-448a-8a60-f49c28ba6dfb.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0555-9045-58 00555904558 6 POUCH in 1 CARTON (0555-9045-58) / 1 BLISTER PACK in 1 POUCH (0555-9045-79) / 1 KIT in 1 BLISTER PACK 6 pouch 2001-04-02 0000-00-00 No No Current 0555-9045-79 00555904579 1 in 1 BLISTER PACK Historical