Home NDC 0113-2003 Option 2
Product NDC 0113-2003
11-digit product format 001132003
Labeler code 0113
Product ID 0113-2003_81d8cf01-db5e-44c9-842b-eec3f3793ea1
Type HUMAN OTC DRUG
Nonproprietary name levonorgestrel
Dosage form TABLET
Route ORAL
Labeler L. Perrigo Company
Application ANDA202334
Marketing category ANDA
Marketing start 2016-01-29
Substance LEVONORGESTREL
Active strength 1.5 mg/1
Pharmacologic classes Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC]
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202334-001 LEVONORGESTREL LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202334-001 LEVONORGESTREL 1.5MG TABLET / ORAL 2014-08-20 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Option 2
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LEVONORGESTREL 1.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5W7SIA7YZW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 483325 Internal RxNorm lookup 1736014 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0113-2003-12 Option 2 1 in 1 BLISTER PACK TABLET 1 5 0113-2003-12 Option 2 1 in 1 CARTON TABLET 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0113-2003 OPTION 2 (LEVONORGESTREL) TABLET [L. PERRIGO COMPANY] 5 Current NDC, Legacy NDC, 2 package rows 20200812_9b9e9352-3e4d-4ec3-96aa-8fd58d82fe96.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 · 2 matching rows.
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 0113-2003-12 00113200312 1 BLISTER PACK in 1 CARTON (0113-2003-12) / 1 TABLET in 1 BLISTER PACK 1 blister pack 2016-01-29 0000-00-00 No No Current