Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate

Product NDC
69238-1686
11-digit product format
692381686
Labeler code
69238
Product ID
69238-1686_eaacb828-e8db-45c4-882b-a6ddf46bf7f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate
Dosage form
KIT
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA214292
Marketing category
ANDA
Marketing start
2021-07-26
NDC exclude flag
No
Listing certified through
2026-12-31
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
A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.02MG;1MGCAPSULE / ORAL2021-07-20

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
2026-02-19 14:30 UTC2026-02A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-204b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-20782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORALAB2021-07-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A214292-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGCAPSULE / ORAL2021-07-20a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A214292-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A214292-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A214292-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A214292-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A214292-001AB1782e0a99824c…
2024-02-18 07:12 UTC2024-02A214292-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A214292-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A214292-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A214292-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A214292-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A214292-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A214292-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A214292-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A214292-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A214292-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A214292-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A214292-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate
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
1421459Internal RxNorm lookup
1421460Internal RxNorm lookup
1421461Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e145ebc7-b6c0-474b-a712-c6f3b2342998Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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782f1593-b73e-4d35-8017-647969d714d8Product name420240805
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1a545a57-aed5-4b6e-b1f9-a93c26d50effProduct name120230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
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20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
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d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-08-23These highlights do not include all the information needed to use NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES safely and effectively. See full prescribing information for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES. NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL capsules and ferrous fumarate capsules, for oral use Initial U.S. Approval: 1968
2023-08-23These highlights do not include all the information needed to use NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES safely and effectively. See full prescribing information for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES. NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL capsules and ferrous fumarate capsules, for oral use Initial U.S. Approval: 1968
2023-01-30These highlights do not include all the information needed to use NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES safely and effectively. See full prescribing information for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES. NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL capsules and ferrous fumarate capsules, for oral use Initial U.S. Approval: 1968
2023-01-30These highlights do not include all the information needed to use NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES safely and effectively. See full prescribing information for NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL CAPSULES AND FERROUS FUMARATE CAPSULES. NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL capsules and ferrous fumarate capsules, for oral use Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1686-3Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate5 in 1 TRAYKIT512
69238-1686-6Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate1 in 1 CARTONKIT112
69238-1686-6Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate1 in 1 BLISTER PACKKIT112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1686NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE KIT [AMNEAL PHARMACEUTICALS NY LLC]12Current NDC, Legacy NDC, 3 package rows20230824_e145ebc7-b6c0-474b-a712-c6f3b2342998.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norethindrone Acetate and Ethinyl Estradiol, and Ferrous FumarateNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATEAmneal Pharmaceuticals LLCe145ebc7-b6c0-474b-a712-c6f3b23429982023-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214292
application number: ANDA214292
ndc (product): 69238-1686

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421461{24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Capsule) / 4 (ferrous fumarate 75 MG Oral Capsule) } PackGPCKe145ebc7-b6c0-474b-a712-c6f3b234299812
1421461Eth estra-Noreth Ac 0.02-1 MG (24) Oral Capsule / Ferr fum 75 MG (4) Oral Capsule 28 Day PackPSNe145ebc7-b6c0-474b-a712-c6f3b234299812
1421459ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral CapsulePSNe145ebc7-b6c0-474b-a712-c6f3b234299812
1421460ferrous fumarate 75 MG Oral CapsulePSNe145ebc7-b6c0-474b-a712-c6f3b234299812
1421459ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral CapsuleSCDe145ebc7-b6c0-474b-a712-c6f3b234299812
1421460ferrous fumarate 75 MG Oral CapsuleSCDe145ebc7-b6c0-474b-a712-c6f3b234299812
1421461ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Capsule / ferrous fumarate 75 MG Oral Capsule 28 day PackSYe145ebc7-b6c0-474b-a712-c6f3b234299812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1686-3692381686035 CARTON in 1 TRAY (69238-1686-3) / 1 BLISTER PACK in 1 CARTON (69238-1686-6) / 1 KIT in 1 BLISTER PACK5 carton2021-07-260000-00-00NoNoCurrent
69238-1686-6692381686061 in 1 CARTONHistorical