FDA.reportPublic FDA data

Norgestimate and Ethinyl Estradiol

Product NDC
68788-7894
11-digit product format
687887894
Labeler code
68788
Product ID
68788-7894_b15a429d-838c-4a4f-8e5b-c8cd39fd0f9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norgestimate and Ethinyl Estradiol
Dosage form
KIT
Labeler
Preferred Pharmaceuticals Inc
Application
ANDA200494
Marketing category
ANDA
Marketing start
2021-04-29
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-7894IInactivated by FDA2026-08-03
excluded packagepackage68788-789468788-7894-2IInactivated by FDA2026-08-03

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
A200494-001NORGESTIMATE AND ETHINYL ESTRADIOLETHINYL ESTRADIOL; NORGESTIMATE0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28ABRS2011-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200494-001AB

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 22:54:322026-06A200494-001NORGESTIMATE AND ETHINYL ESTRADIOL0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MGTABLET / ORAL-28ABRS2011-06-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200494-001AB1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA8b247e46-203e-4f5b-b5a7-cbd57341c7352026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200494
application number: ANDA200494
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions6ae97238-28cf-4bc9-a4ba-1e2bf4e3c6002023-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200494
application number: ANDA200494
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLProficient Rx LP4a159dcd-8af4-4e59-8f46-7b0fe5c228072022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200494
application number: ANDA200494

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-7894-22025-01-30C16284748780-12cef2736-5c13-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7894-2Norgestimate and Ethinyl Estradiol1 in 1 BLISTER PACKKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7894-2EA - Each68788-789477e99f3b-029d-4f0d-b28e-6b65b742d84012021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7894NORGESTIMATE AND ETHINYL ESTRADIOL KIT [PREFERRED PHARMACEUTICALS INC]3Legacy NDC, 1 package rows20231006_02e5c9a1-6002-499e-abe2-8473a5854178.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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) } PackGPCK02e5c9a1-6002-499e-abe2-8473a58541783
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 PackPSN02e5c9a1-6002-499e-abe2-8473a58541783
748797inert 1 MG Oral TabletPSN02e5c9a1-6002-499e-abe2-8473a58541783
406396norgestimate 0.18 MG / ethinyl estradiol 0.035 MG Oral TabletPSN02e5c9a1-6002-499e-abe2-8473a58541783
687424norgestimate 0.215 MG / ethinyl estradiol 0.035 MG Oral TabletPSN02e5c9a1-6002-499e-abe2-8473a58541783
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN02e5c9a1-6002-499e-abe2-8473a58541783
406396ethinyl estradiol 0.035 MG / norgestimate 0.18 MG Oral TabletSCD02e5c9a1-6002-499e-abe2-8473a58541783
687424ethinyl estradiol 0.035 MG / norgestimate 0.215 MG Oral TabletSCD02e5c9a1-6002-499e-abe2-8473a58541783
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD02e5c9a1-6002-499e-abe2-8473a58541783
748797inert ingredients 1 MG Oral TabletSCD02e5c9a1-6002-499e-abe2-8473a58541783
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY02e5c9a1-6002-499e-abe2-8473a58541783

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7894-2687887894021 KIT in 1 BLISTER PACK (68788-7894-2) 1 kit2021-04-290000-00-00NoNoCurrent