FDA.reportPublic FDA data

Amethyst

Product NDC
0480-3472
11-digit product format
004803472
Labeler code
0480
Product ID
0480-3472_e70f2946-fc53-487c-b37a-d11ee6751735
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levonorgestrel and Ethinyl Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA079218
Marketing category
ANDA
Marketing start
2023-03-01
Substance
LEVONORGESTREL; ETHINYL ESTRADIOL
Active strength
90; 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 System [EPC]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTREL0.02MG;0.09MGTABLET / ORALABRS2011-06-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A079218-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-0684e616aacf4f…
2026-08-18 06:07:402026-07A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-063f01610625f2…
2019-09-15 20:21 UTC2019-09A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079218-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.09MGTABLET / ORALABRS2011-06-06f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A079218-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A079218-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079218-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079218-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079218-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079218-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079218-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079218-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079218-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079218-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079218-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079218-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079218-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079218-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079218-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079218-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079218-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079218-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079218-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079218-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079218-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079218-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079218-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A079218-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079218-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079218-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079218-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A079218-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079218-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079218-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079218-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079218-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079218-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079218-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079218-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079218-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A079218-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A079218-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079218-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079218-001AB1f41ea6bd6efb…

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
Amethyst
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVONORGESTREL90 ug/1
ETHINYL ESTRADIOL20 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5W7SIA7YZWInternal UNII lookup
423D2T571UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
722152Internal RxNorm lookup
751553Internal RxNorm lookup
1112715Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
99073fe0-eac8-44dd-abe6-623fa67d9e79Available on FDA.report

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
0480-3472-24Amethyst1 in 1 CARTONTABLET13
0480-3472-24Amethyst1 in 1 POUCHTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-3472-24EA - Each0480-3472e626d010-4c56-4888-adaa-f71d576de5c012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-3472AMETHYST (LEVONORGESTREL AND ETHINYL ESTRADIOL) TABLET [TEVA PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 2 package rows20230307_99073fe0-eac8-44dd-abe6-623fa67d9e79.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmethystLEVONORGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals, Inc.99073fe0-eac8-44dd-abe6-623fa67d9e792022-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079218
application number: ANDA079218
ndc (product): 0480-3472

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1112715{28 (ethinyl estradiol 0.02 MG / levonorgestrel 0.09 MG Oral Tablet) } Pack [Amethyst 28 Day]BPCK99073fe0-eac8-44dd-abe6-623fa67d9e793
751553{28 (ethinyl estradiol 0.02 MG / levonorgestrel 0.09 MG Oral Tablet) } PackGPCK99073fe0-eac8-44dd-abe6-623fa67d9e793
1112715Amethyst 28 Day PackPSN99073fe0-eac8-44dd-abe6-623fa67d9e793
751553Eth estra-Levonorgest 0.02-0.09 MG (28) Oral Tablet 28 Day PackPSN99073fe0-eac8-44dd-abe6-623fa67d9e793
722152ethinyl estradiol 20 MCG / levonorgestrel 90 MCG Oral TabletPSN99073fe0-eac8-44dd-abe6-623fa67d9e793
722152ethinyl estradiol 0.02 MG / levonorgestrel 0.09 MG Oral TabletSCD99073fe0-eac8-44dd-abe6-623fa67d9e793
1112715Amethyst 28 Day PackSY99073fe0-eac8-44dd-abe6-623fa67d9e793
722152ethinyl estradiol 20 MCG / levonorgestrel 90 MCG Oral TabletSY99073fe0-eac8-44dd-abe6-623fa67d9e793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0480-3472-24004803472241 POUCH in 1 CARTON (0480-3472-24) / 1 BLISTER PACK in 1 POUCH / 28 TABLET in 1 BLISTER PACK1 pouch2023-03-010000-00-00NoNoCurrent