Home NDC 52544-295 Amethyst
Product NDC 52544-295
11-digit product format 525440295
Labeler code 52544
Product ID 52544-295_ffaba3df-086b-42fd-9469-80a43ffd8066
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel and Ethinyl Estradiol
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA079218
Marketing category ANDA
Marketing start 2011-06-13
Marketing end 0000-00-00
Substance ETHINYL ESTRADIOL; LEVONORGESTREL
Active strength 20 ug/1; ug/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52544-295-28 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52544-295-28 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52544-295-28 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52544-295-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52544-295-28 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52544-295-28 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52544-295-28 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52544-295-28 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52544-295-28 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52544-295-28 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52544-295-28 367a005e9d99…383a685ebd0f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A079218-001 AB
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 2 · 43 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 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079218-001 LEVONORGESTREL AND ETHINYL ESTRADIOL 0.02MG;0.09MG TABLET / ORAL AB RS 2011-06-06 f41ea6bd6efb…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U AMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [WATSON PHARMA, INC.] 3 LEVONORGESTREL ACTIVE INGREDIENT 5W7SIA7YZW AMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [WATSON PHARMA, INC.] 3 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U AMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [WATSON PHARMA, INC.] 3 LEVONORGESTREL ACTIVE MOIETY 5W7SIA7YZW AMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [WATSON PHARMA, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [WATSON PHARMA, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [WATSON PHARMA, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X AMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [WATSON PHARMA, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [WATSON PHARMA, INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E AMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [WATSON PHARMA, INC.] 3
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Amethyst LEVONORGESTREL AND ETHINYL ESTRADIOL Teva Pharmaceuticals, Inc. 99073fe0-eac8-44dd-abe6-623fa67d9e79 2022-01-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 079218 application number: ANDA079218
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52544-295-28 52544029528 1 POUCH in 1 CARTON (52544-295-28) > 1 BLISTER PACK in 1 POUCH > 28 TABLET in 1 BLISTER PACK 1 pouch 2011-06-13 0000-00-00 No No Current