FDA.reportPublic FDA data

Melodetta 24 Fe

Product NDC
69238-1031
Requested package NDC
69238-1031-7
11-digit product format
692381031
Labeler code
69238
Product ID
69238-1031_ef7d6985-bc76-4ecc-9774-7edfacbef22c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Dosage form
KIT
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA207514
Marketing category
ANDA
Marketing start
2017-09-21
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
A207514-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.02MG;1MGTABLET / ORAL2017-09-11

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 22:54:322026-06A207514-001NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE0.02MG;1MGTABLET / ORAL2017-09-11a50c72e98297…

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
Norethindrone Acetate and Ethinyl Estradiol and Ferrous FumarateNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAmneal Pharmaceuticals NY LLCd4fa03d8-0ae0-497f-ba4e-76f03fd7a3ab2023-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207514
application number: ANDA207514
Melodetta 24 FeNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEAmneal Pharmaceuticals NY LLCca89a8e3-4df1-4e4b-9da7-0233770e542b2023-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207514
application number: ANDA207514
ndc (package): 69238-1031-7
ndc (product): 69238-1031
ndc11 (package): 69238103107

Additional Listing Data#

Finished product
Yes
Brand name base
Melodetta 24 Fe
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259176Internal RxNorm lookup
1426288Internal RxNorm lookup
1426600Internal RxNorm lookup
1944656Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca89a8e3-4df1-4e4b-9da7-0233770e542bAvailable 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
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
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
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
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
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
c21bcd2e-ecbd-48e6-ab68-12cc12256c0fProduct name220190213
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
f6ac5560-6d3b-d281-41d2-adc50d283c20Product name320170228
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
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
69238-1031-6Melodetta 24 Fe1 in 1 BLISTER PACKKIT120
69238-1031-7Melodetta 24 Fe3 in 1 CARTONKIT320

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1031-6EA - Each69238-10319f1e85d0-b554-45f9-a90c-641a01f49b3912017-10-13
69238-1031-7EA - Each69238-10316eb4cf15-8e72-4010-92ac-75745daffffb12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1031MELODETTA 24 FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [AMNEAL PHARMACEUTICALS NY LLC]20Current NDC, Legacy NDC, 2 package rows20230707_ca89a8e3-4df1-4e4b-9da7-0233770e542b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1944656{24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Chewable Tablet) / 4 (ferrous fumarate 75 MG Oral Tablet) } Pack [Melodetta 24 Fe Chewable 28 Day]BPCKca89a8e3-4df1-4e4b-9da7-0233770e542b20
1426600{24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Chewable Tablet) / 4 (ferrous fumarate 75 MG Oral Tablet) } PackGPCKca89a8e3-4df1-4e4b-9da7-0233770e542b20
1426600Eth estra-Noreth Ac 0.02-1 MG (24) Chewable Tablet / Ferr fum 75 MG (4) Oral Tablet 28 Day PackPSNca89a8e3-4df1-4e4b-9da7-0233770e542b20
259176ferrous fumarate 75 MG Oral TabletPSNca89a8e3-4df1-4e4b-9da7-0233770e542b20
1944656Melodetta 24 Fe Chewable 28 Day PackPSNca89a8e3-4df1-4e4b-9da7-0233770e542b20
1426288norethindrone acetate 1 MG / ethinyl estradiol 20 MCG Chewable TabletPSNca89a8e3-4df1-4e4b-9da7-0233770e542b20
1426288ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Chewable TabletSCDca89a8e3-4df1-4e4b-9da7-0233770e542b20
259176ferrous fumarate 75 MG Oral TabletSCDca89a8e3-4df1-4e4b-9da7-0233770e542b20
1426288ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Chewable TabletSYca89a8e3-4df1-4e4b-9da7-0233770e542b20
1944656Melodetta 24 Fe Chewable 28 Day PackSYca89a8e3-4df1-4e4b-9da7-0233770e542b20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1031-7692381031073 BLISTER PACK in 1 CARTON (69238-1031-7) / 1 KIT in 1 BLISTER PACK (69238-1031-6) 3 blister pack2017-09-210000-00-00NoNoCurrent