FDA.reportPublic FDA data

Norgestimate and Ethinyl Estradiol

Product NDC
68462-309
11-digit product format
684620309
Labeler code
68462
Product ID
68462-309_fbb3fa97-10f6-482a-8d60-e67563ec2bfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norgestimate and Ethinyl Estradiol
Dosage form
KIT
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA200538
Marketing category
ANDA
Marketing start
2012-04-06
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
A200538-001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATE0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200538-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-053f01610625f2…
2019-09-15 20:21 UTC2019-09A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200538-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200538-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200538-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200538-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200538-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200538-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200538-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200538-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200538-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200538-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200538-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200538-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200538-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200538-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200538-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200538-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200538-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200538-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200538-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200538-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200538-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A200538-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200538-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200538-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200538-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A200538-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200538-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200538-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200538-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200538-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200538-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200538-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200538-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200538-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A200538-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A200538-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200538-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200538-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200538-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A200538-001AB1cb3db0bc1861…

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
240128Internal RxNorm lookup
406396Internal RxNorm lookup
687424Internal RxNorm lookup
748797Internal RxNorm lookup
749784Internal RxNorm lookup
749860Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b247e46-203e-4f5b-b5a7-cbd57341c735Available 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
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
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-309-29Norgestimate and Ethinyl Estradiol3 in 1 CARTONKIT317
68462-309-84Norgestimate and Ethinyl Estradiol1 in 1 BLISTER PACKKIT117
68462-309-29Norgestimate and Ethinyl Estradiol3 in 1 CARTONKIT35
68462-309-84Norgestimate and Ethinyl Estradiol1 in 1 BLISTER PACKKIT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-309-29EA - Each68462-309a21653d2-bcd2-4d67-b1eb-f518c8c5e3c612012-07-24
68462-309-84EA - Each68462-3092b31643c-2081-4343-86ea-abe8ed172c8312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
NORGESTIMATEACTIVE MOIETYC291HFX4DYNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
POVIDONE K30INACTIVE INGREDIENTU725QWY32XNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
TALCINACTIVE INGREDIENT7SEV7J4R1UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]8
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
NORGESTIMATEACTIVE MOIETYC291HFX4DYNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
POVIDONEINACTIVE INGREDIENTFZ989GH94ENORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5
TALCINACTIVE INGREDIENT7SEV7J4R1UNORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-309NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK PHARMACEUTICALS INC., USA]14Current NDC, Legacy NDC, 2 package rows20230807_8b247e46-203e-4f5b-b5a7-cbd57341c735.zip
68462-309NORGESTIMATE AND ETHINYL ESTRADIOL KIT [GLENMARK GENERICS INC., USA]5Current NDC, Legacy NDC, 2 package rows20120413_beabee48-1912-47bf-a9b5-d5c426c4fcc2.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions35c6507c-555a-45ed-aaf6-8695831de71a2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200538
application number: ANDA200538
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA8b247e46-203e-4f5b-b5a7-cbd57341c7352026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200538
application number: ANDA200538
ndc (product): 68462-309

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK8b247e46-203e-4f5b-b5a7-cbd57341c73517
749784{7 (ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK8b247e46-203e-4f5b-b5a7-cbd57341c73517
749784Eth estra-Norgestim 0.035-0.18 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.215 MG (7) Oral Tablet / Eth estra-Norgestim 0.035-0.25 MG (7) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN8b247e46-203e-4f5b-b5a7-cbd57341c73517
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN8b247e46-203e-4f5b-b5a7-cbd57341c73517
748797inert 1 MG Oral TabletPSN8b247e46-203e-4f5b-b5a7-cbd57341c73517
406396norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral TabletPSN8b247e46-203e-4f5b-b5a7-cbd57341c73517
687424norgestimate 0.215 MG / ethinyl estradiol 0.035 MG Oral TabletPSN8b247e46-203e-4f5b-b5a7-cbd57341c73517
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN8b247e46-203e-4f5b-b5a7-cbd57341c73517
406396ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral TabletSCD8b247e46-203e-4f5b-b5a7-cbd57341c73517
687424ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral TabletSCD8b247e46-203e-4f5b-b5a7-cbd57341c73517
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD8b247e46-203e-4f5b-b5a7-cbd57341c73517
748797inert ingredients 1 MG Oral TabletSCD8b247e46-203e-4f5b-b5a7-cbd57341c73517
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY8b247e46-203e-4f5b-b5a7-cbd57341c73517
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK35c6507c-555a-45ed-aaf6-8695831de71a12
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN35c6507c-555a-45ed-aaf6-8695831de71a12
748797inert 1 MG Oral TabletPSN35c6507c-555a-45ed-aaf6-8695831de71a12
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN35c6507c-555a-45ed-aaf6-8695831de71a12
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD35c6507c-555a-45ed-aaf6-8695831de71a12
748797inert ingredients 1 MG Oral TabletSCD35c6507c-555a-45ed-aaf6-8695831de71a12
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY35c6507c-555a-45ed-aaf6-8695831de71a12
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK3e8149e1-ada2-4f3d-996b-466759cbb3445
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCKbeabee48-1912-47bf-a9b5-d5c426c4fcc25
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN3e8149e1-ada2-4f3d-996b-466759cbb3445
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSNbeabee48-1912-47bf-a9b5-d5c426c4fcc25
748797inert 1 MG Oral TabletPSN3e8149e1-ada2-4f3d-996b-466759cbb3445
748797inert 1 MG Oral TabletPSNbeabee48-1912-47bf-a9b5-d5c426c4fcc25
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN3e8149e1-ada2-4f3d-996b-466759cbb3445
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSNbeabee48-1912-47bf-a9b5-d5c426c4fcc25
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCDbeabee48-1912-47bf-a9b5-d5c426c4fcc25
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD3e8149e1-ada2-4f3d-996b-466759cbb3445
748797inert ingredients 1 MG Oral TabletSCDbeabee48-1912-47bf-a9b5-d5c426c4fcc25
748797inert ingredients 1 MG Oral TabletSCD3e8149e1-ada2-4f3d-996b-466759cbb3445
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSYbeabee48-1912-47bf-a9b5-d5c426c4fcc25
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY3e8149e1-ada2-4f3d-996b-466759cbb3445

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-309-29684620309293 BLISTER PACK in 1 CARTON (68462-309-29) / 1 KIT in 1 BLISTER PACK (68462-309-84) 3 blister pack2012-04-060000-00-00NoNoCurrent
68462-309-84684620309841 in 1 BLISTER PACKHistorical