FDA.reportPublic FDA data

Norgestimate and Ethinyl Estradiol

Product NDC
68462-309
Requested package NDC
68462-309-29
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A200538-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG;0.25MGTABLET / ORAL-28AB2012-04-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200538-001AB1a50c72e98297…

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
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 (package): 68462-309-29
ndc (product): 68462-309
ndc11 (package): 68462030929

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
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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

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