OPTION 2

Product NDC: 0113-8099
11-digit product format: 001138099
Labeler code: 0113
Product ID: 0113-8099_df911826-f2da-4ab3-b86d-5cb8dfbbb789
Type: HUMAN OTC DRUG
Nonproprietary name: levonorgestrel
Dosage form: TABLET
Route: ORAL
Labeler: L. Perrigo Company
Application: ANDA202334
Marketing category: ANDA
Marketing start: 2026-04-20
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 System [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202334-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2014-08-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202334-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2014-08-20	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: OPTION 2
Listing expiration: 2027-12-31

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7d7b9e61-9f3d-477d-b74d-b0cc725f9bba	Available on FDA.report

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OPTION 2	LEVONORGESTREL	L. Perrigo Company	7d7b9e61-9f3d-477d-b74d-b0cc725f9bba	2026-06-25	Warnings	Exact identifier application applno (ANDA): 202334 application number: ANDA202334 ndc (product): 0113-8099
Option 2	LEVONORGESTREL	L. Perrigo Company	9b9e9352-3e4d-4ec3-96aa-8fd58d82fe96	2020-07-30	Warnings	Exact identifier application applno (ANDA): 202334 application number: ANDA202334

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5W7SIA7YZW	LEVONORGESTREL	797-63-7	LEVONORGESTREL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0113-8099-12	00113809912	1 BLISTER PACK in 1 CARTON (0113-8099-12) / 1 TABLET in 1 BLISTER PACK	1 blister pack	2026-04-20	No	No	Current