LEVONORGESTREL AND ETHINYL ESTRADIOL

Product NDC
0378-6550
11-digit product format
003786550
Labeler code
0378
Product ID
0378-6550_a668d9c7-2208-4aa5-8e53-ce2c3c8fcdb3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levonorgestrel and ethinyl estradiol
Dosage form
KIT
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA091663
Marketing category
ANDA
Marketing start
2013-08-16
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0378-6550DDiscontinued by firm2026-09-14
excluded packagepackage0378-65500378-6550-53DDiscontinued by firm2026-09-14

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
A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTREL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091663-001AB

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 22:38:342026-08A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-2184e616aacf4f…
2026-08-18 06:07:402026-07A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-213f01610625f2…
2019-09-15 20:21 UTC2019-09A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091663-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.03MG;0.15MGTABLET / ORAL-28AB2012-12-21f41ea6bd6efb…

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 22:38:342026-08A091663-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A091663-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091663-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091663-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091663-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091663-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091663-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091663-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091663-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091663-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091663-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091663-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091663-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091663-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091663-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091663-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091663-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091663-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091663-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091663-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091663-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091663-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091663-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091663-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091663-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091663-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091663-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091663-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091663-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091663-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091663-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091663-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091663-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091663-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091663-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091663-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091663-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091663-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091663-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091663-001AB1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

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
0378-6550-53LEVONORGESTREL AND ETHINYL ESTRADIOL3 in 1 CARTONKIT319
0378-6550-85LEVONORGESTREL AND ETHINYL ESTRADIOL1 in 1 BLISTER PACKKIT119
0378-6550-85LEVONORGESTREL AND ETHINYL ESTRADIOL1 in 1 POUCHKIT119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6550-53EA - Each0378-65507c39e2f5-8f91-4700-a739-ebb3ab36f98512013-02-13
0378-6550-85EA - Each0378-65501b7d2373-4131-4aeb-ae56-9baaebf516dc12018-11-06

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-6550LEVONORGESTREL AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.]19Legacy NDC, 3 package rows20250221_27178b07-42bd-496d-aebb-d9428664ee72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
748878{21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK27178b07-42bd-496d-aebb-d9428664ee7219
748878Eth estra-Levnorgest 0.03-0.15 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN27178b07-42bd-496d-aebb-d9428664ee7219
748797inert 1 MG Oral TabletPSN27178b07-42bd-496d-aebb-d9428664ee7219
238019levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral TabletPSN27178b07-42bd-496d-aebb-d9428664ee7219
238019ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral TabletSCD27178b07-42bd-496d-aebb-d9428664ee7219
748797inert ingredients 1 MG Oral TabletSCD27178b07-42bd-496d-aebb-d9428664ee7219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-6550-53003786550533 POUCH in 1 CARTON (0378-6550-53) > 1 BLISTER PACK in 1 POUCH (0378-6550-85) > 1 KIT in 1 BLISTER PACK3 pouch2013-08-160000-00-00NoNoCurrent
0378-6550-85003786550851 in 1 BLISTER PACKHistorical