FDA.reportPublic FDA data

LEVONORGESTREL AND ETHINYL ESTRADIOL

Product NDC
0378-7281
Requested package NDC
0378-7281-53
11-digit product format
003787281
Labeler code
0378
Product ID
0378-7281_19d674c0-9bdd-4100-a3f3-b21a574c49ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levonorgestrel and Ethinyl Estradiol
Dosage form
KIT
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA200490
Marketing category
ANDA
Marketing start
2015-04-27
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0378-72810378-7281-53DDiscontinued by firm2026-10-05

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
A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTREL0.03MG;0.15MGTABLET / ORALAB2015-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200490-001AB

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 22:38:342026-08A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-2184e616aacf4f…
2026-08-18 06:07:402026-07A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-213f01610625f2…
2019-09-15 20:21 UTC2019-09A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200490-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORALAB2015-04-21f41ea6bd6efb…

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 22:38:342026-08A200490-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A200490-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200490-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200490-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200490-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200490-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200490-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200490-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200490-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200490-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200490-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200490-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200490-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200490-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200490-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200490-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200490-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200490-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200490-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200490-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200490-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200490-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200490-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A200490-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200490-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200490-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200490-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A200490-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200490-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200490-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200490-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200490-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200490-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200490-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200490-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200490-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A200490-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A200490-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200490-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200490-001AB1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7281-53EA - Each0378-7281b95bb4f7-811a-4cda-a732-258ffeaf0cc112015-05-05
0378-7281-85EA - Each0378-72814e91d0a4-aa5c-4594-a9cc-5db57c503cf712022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
LEVONORGESTRELACTIVE INGREDIENT5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571ULEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
LEVONORGESTRELACTIVE MOIETY5W7SIA7YZWLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQULEVONORGESTREL AND ETHINYL ESTRADIOL (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MYLAN PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7281LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]11Legacy NDC20250221_af93fc89-c813-4a8c-9909-44729ab25a64.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
INTROVALELEVONORGESTREL AND ETHINYL ESTRADIOL TABLETSXiromed LLC24abb5e1-5be4-87e7-404c-d8c2db25ffd02024-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200490
application number: ANDA200490

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-7281-53003787281533 POUCH in 1 CARTON (0378-7281-53) > 1 BLISTER PACK in 1 POUCH (0378-7281-85) > 1 KIT in 1 BLISTER PACK3 pouch2015-04-270000-00-00NoNoCurrent