LEVONORGESTREL AND ETHINYL ESTRADIOL

Manufacturer: Jai Pharma Limited
Effective date: 2016-09-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:20:53

Label at a glance#

ProductLEVONORGESTREL AND ETHINYL ESTRADIOL

Active ingredientLEVONORGESTREL, ETHINYL ESTRADIOL

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57994-008-90	2020-01-31	C162847	48780-1	9d75b9d0-a4d7-f424-e053-dadaa90a57ce	Levonorgestrel and Ethinyl Estradiol Tablets USP, (0.1 mg/0.02 mg) and Ethinyl Estradiol Tablets USP, (0.01 mg)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

LEVONORGESTREL AND ETHINYL ESTRADIOL
LEVONORGESTREL
ETHINYL ESTRADIOL
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLACRILIN POTASSIUM
.ALPHA.-TOCOPHEROL, DL-
ANHYDROUS LACTOSE
CELLULOSE, MICROCRYSTALLINE
FD&C YELLOW NO. 6
POVIDONE K25

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57994-008	57994-008-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LEVONORGESTREL	5W7SIA7YZW	ACTIB
ETHINYL ESTRADIOL	423D2T571U	ACTIB
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLACRILIN POTASSIUM	0BZ5A00FQU	IACT
ETHINYL ESTRADIOL	423D2T571U	ACTIB
.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLACRILIN POTASSIUM	0BZ5A00FQU	IACT
POVIDONE K25	K0KQV10C35	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	ETHINYL ESTRADIOL; LEVONORGESTREL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB		2015-06-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A200493-001	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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200493-001	LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL	0.02MG,0.1MG;0.01MG,N/A	TABLET / ORAL	AB	2015-06-17	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A200493-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200493-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200493-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200493-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200493-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200493-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200493-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200493-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200493-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200493-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200493-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200493-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200493-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200493-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200493-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200493-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200493-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200493-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200493-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200493-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200493-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200493-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200493-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200493-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200493-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200493-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200493-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200493-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200493-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200493-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200493-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200493-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200493-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200493-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200493-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200493-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200493-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200493-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200493-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200493-001	AB	1	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b175b0fd-79f5-4001-b371-30e859522c5b			4dfb7ef1-c14a-4175-9409-a30232844c33	2016-09-27		Exact identifier spl id: b175b0fd-79f5-4001-b371-30e859522c5b spl set id: 4dfb7ef1-c14a-4175-9409-a30232844c33

Reported adverse events (FAERS/openFDA)#

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