Home NDC 53002-2616-1 Microgestin Fe 1/20
Product NDC 53002-2616
Requested package NDC 53002-2616-1
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091454-001 LARIN FE 1/20 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET / ORAL-28 AB 2013-08-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091454-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A091454-001 LARIN FE 1/20 0.02MG;1MG TABLET / ORAL-28 AB 2013-08-26 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A091454-001 AB 1 a50c72e98297…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53002-2616-1 Microgestin Fe 1/20 1 in 1 CARTON KIT 1 3 53002-2616-1 Microgestin Fe 1/20 1 in 1 BLISTER PACK KIT 1 3 53002-2616-3 Microgestin Fe 1/20 3 in 1 CARTON KIT 3 3 53002-2616-3 Microgestin Fe 1/20 1 in 1 BLISTER PACK KIT 1 3 53002-2616-6 Microgestin Fe 1/20 6 in 1 CARTON KIT 6 3 53002-2616-6 Microgestin Fe 1/20 1 in 1 BLISTER PACK KIT 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53002-2616 MICROGESTIN FE 1/20 (NORETHINDRONE ACETATE/ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [RPK PHARMACEUTICALS, INC.] 3 Legacy NDC, 6 package rows 20220421_9bff0c82-55b0-4eea-9c91-534341be0a05.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53002-2616-1 53002261601 1 BLISTER PACK in 1 CARTON (53002-2616-1) > 1 KIT in 1 BLISTER PACK 1 blister pack 2021-12-31 0000-00-00 No No Current