FDA.reportPublic FDA data

Levonorgestrel and Ethinyl Estradiol

Product NDC
60505-4898
Requested package NDC
60505-4898-8
11-digit product format
605054898
Labeler code
60505
Product ID
60505-4898_4ea39445-1e59-ac2e-e063-6294a90a61ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Levonorgestrel and Ethinyl Estradiol
Dosage form
KIT
Labeler
Apotex Corp.
Application
ANDA207065
Marketing category
ANDA
Marketing start
2026-04-04
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; LEVONORGESTREL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207065-001AB1

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A207065-001LEVONORGESTREL AND ETHINYL ESTRADIOL0.02MG;0.1MGTABLET / ORAL-28AB12020-08-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A207065-001AB11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLApotex Corp.a7a1fb54-5a24-40ff-b862-dea256309b7d2026-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207065
application number: ANDA207065
ndc (package): 60505-4898-8
ndc (product): 60505-4898
ndc11 (package): 60505489808
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLNaari Pte Limitedf1a3bfe0-1057-4120-be7e-d7b3570d54182024-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207065
application number: ANDA207065

Additional Listing Data#

Finished product
Yes
Brand name base
Levonorgestrel and Ethinyl Estradiol
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
242297Internal RxNorm lookup
748797Internal RxNorm lookup
748868Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7a1fb54-5a24-40ff-b862-dea256309b7dAvailable 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
60505-4898-8Levonorgestrel and Ethinyl Estradiol1 in 1 BLISTER PACKKIT11
60505-4898-8Levonorgestrel and Ethinyl Estradiol3 in 1 CARTONKIT31

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
748868{21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKa7a1fb54-5a24-40ff-b862-dea256309b7d1
748868Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNa7a1fb54-5a24-40ff-b862-dea256309b7d1
748797inert 1 MG Oral TabletPSNa7a1fb54-5a24-40ff-b862-dea256309b7d1
242297levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral TabletPSNa7a1fb54-5a24-40ff-b862-dea256309b7d1
242297ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral TabletSCDa7a1fb54-5a24-40ff-b862-dea256309b7d1
748797inert ingredients 1 MG Oral TabletSCDa7a1fb54-5a24-40ff-b862-dea256309b7d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60505-4898-8605054898083 BLISTER PACK in 1 CARTON (60505-4898-8) / 1 KIT in 1 BLISTER PACK3 blister pack2026-04-04NoNoCurrent