FDA.reportPublic FDA data

Microgestin Fe 1/20

Product NDC
53002-2616
11-digit product format
530022616
Labeler code
53002
Product ID
53002-2616_ced3a7e4-691a-41c6-9f4a-191069262bc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate
Dosage form
KIT
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA091454
Marketing category
ANDA
Marketing start
2020-10-12
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
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d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-2616-12025-01-30C16284748780-12cef2736-b474-d83d-e063-dadaa90ab31fMicrogestin® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution.
53002-2616-32025-01-30C16284748780-12cef2736-b474-d83d-e063-dadaa90ab31fMicrogestin® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution.
53002-2616-62025-01-30C16284748780-12cef2736-b474-d83d-e063-dadaa90ab31fMicrogestin® Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets*) *Ferrous fumarate tablets are not USP for dissolution.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2616-1Microgestin Fe 1/201 in 1 CARTONKIT13
53002-2616-1Microgestin Fe 1/201 in 1 BLISTER PACKKIT13
53002-2616-3Microgestin Fe 1/203 in 1 CARTONKIT33
53002-2616-3Microgestin Fe 1/201 in 1 BLISTER PACKKIT13
53002-2616-6Microgestin Fe 1/206 in 1 CARTONKIT63
53002-2616-6Microgestin Fe 1/201 in 1 BLISTER PACKKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2616MICROGESTIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 6 package rows20220421_9bff0c82-55b0-4eea-9c91-534341be0a05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1358775{21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack [Microgestin Fe 1/20 28 Day]BPCK9bff0c82-55b0-4eea-9c91-534341be0a053
1358763{21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } PackGPCK9bff0c82-55b0-4eea-9c91-534341be0a053
1358763Eth-estra-Noreth Ac 0.02-1 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day PackPSN9bff0c82-55b0-4eea-9c91-534341be0a053
259176ferrous fumarate 75 MG Oral TabletPSN9bff0c82-55b0-4eea-9c91-534341be0a053
1358775MICROGESTIN Fe 1/20 28 Day PackPSN9bff0c82-55b0-4eea-9c91-534341be0a053
1358762norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral TabletPSN9bff0c82-55b0-4eea-9c91-534341be0a053
1358762ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral TabletSCD9bff0c82-55b0-4eea-9c91-534341be0a053
259176ferrous fumarate 75 MG Oral TabletSCD9bff0c82-55b0-4eea-9c91-534341be0a053
1358762ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral TabletSY9bff0c82-55b0-4eea-9c91-534341be0a053
1358775Microgestin Fe 1/20 28 Day PackSY9bff0c82-55b0-4eea-9c91-534341be0a053

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2616-1530022616011 BLISTER PACK in 1 CARTON (53002-2616-1) > 1 KIT in 1 BLISTER PACK1 blister pack2021-12-310000-00-00NoNoCurrent
53002-2616-3530022616033 BLISTER PACK in 1 CARTON (53002-2616-3) > 1 KIT in 1 BLISTER PACK3 blister pack2021-12-310000-00-00NoNoCurrent
53002-2616-6530022616066 BLISTER PACK in 1 CARTON (53002-2616-6) > 1 KIT in 1 BLISTER PACK6 blister pack2021-12-310000-00-00NoNoCurrent