Levonorgestrel

Manufacturer: Pharmacist Pharmaceutical, LLC | Novel Laboratories, Inc.
Effective date: 2014-04-15
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:39:00

Label at a glance#

ProductLevonorgestrel

Active ingredientLEVONORGESTREL

Label structure12 sections

Dosage and administration

women 17 years of age or older: take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work. if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose

Contacts and useful links#

PhoneLabel contact1-800-224-4606

PhonePoison Help1-800-222-1222

Websitewww.ecpill.com

www.ecpill.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Levonorgestrel 1.5mg

Purpose

OTC - PURPOSE SECTION

Emergency contraceptive

Indications

INDICATIONS & USAGE SECTION

Use for women 17 years of age and older to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you have ever had an allergic reaction to levonorgestrel

Sexually transmitted diseases (STDs) alert: This product does not protect against HIV/AIDS or other STDs

Do not use

OTC - DO NOT USE SECTION

if you are already pregnant (because it will not work)
for regular birth control

When using this product you may have

OTC - WHEN USING SECTION

menstrual changes
nausea
lower stomach (abdominal) pain
tiredness
headache
dizziness
breast pain
vomiting

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

women 17 years of age or older:

take as soon as possible within 72 hours (3 days) after unprotected sex. The sooner you take it the better it will work.
if you vomit within 2 hours after taking the medication, call a healthcare professional to find out if you should repeat the dose

Other information

SPL UNCLASSIFIED SECTION

read the instructions, warnings and enclosed product leaflet before use
this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus (implantation).
do not use if carton is open or blister seal is broken or missing
store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, pregelatinized starch, lactose monohydrate, magnesium stearate and talc

Questions or comments?

OTC - QUESTIONS SECTION

For more information or to speak to a healthcare professional, call 1-800-224-4606 or visit www.ecpill.com

Levonorgestrel Tablet
Emergency Contraceptive
What You Need to Know

What is Levonorgestrel Tablet?

Levonorgestrel Tablet is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex. It is a backup method of preventing pregnancy and should not be used as regular birth control.

What Levonorgestrel Tablet is not.

Levonorgestrel Tablet will not work if you are already pregnant and will not affect an existing pregnancy. Levonorgestrel Tablet will not protect you from HIV infection (the virus that causes AIDS) and other sexually transmitted diseases (STDs).

When should I use Levonorgestrel Tablet?

The sooner you take emergency contraception, the better it works. You should use Levonorgestrel Tablet within 72 hours (3 days) after you have had unprotected sex.

Levonorgestrel Tablet is a backup or emergency method of birth control you can use when:

Your regular birth control was used incorrectly or failed
You did not use any birth control method

When not to use Levonorgestrel Tablet.

Levonorgestrel Tablet should not be used:

as a regular birth control method, because it’s not as effective as regular birth control.
if you are already pregnant, because it will not work.
if you are allergic to levonorgestrel or any other ingredients in Levonorgestrel Tablet.

How does Levonorgestrel Tablet work?

Levonorgestrel Tablet is one tablet with levonorgestrel, a hormone that has been used in many birth control pills for several decades. Levonorgestrel Tablet contains a higher dose of levonorgestrel than birth control pills, but works in a similar way to prevent pregnancy. It works mainly by stopping the release of an egg from the ovary. It is possible that Levonorgestrel Tablet may also work by preventing fertilization of an egg (the uniting of sperm with the egg) or by preventing attachment (implantation) to the uterus (womb).

How can I get the best results from Levonorgestrel Tablet?

You have 72 hours (3 days) to try to prevent pregnancy after birth control failure or unprotected sex. The sooner you take Levonorgestrel Tablet, the better it works.

How effective is Levonorgestrel Tablet?

If Levonorgestrel Tablet is taken as directed, it can significantly decrease the chance that you will get pregnant. About 7 out of every 8 women who would have gotten pregnant will not become pregnant.

How will I know Levonorgestrel Tablet worked?

You will know Levonorgestrel Tablet has been effective when you get your next period, which should come at the expected time, or within a week of the expected time. If your period is delayed beyond 1 week, it is possible you may be pregnant. You should get a pregnancy test and follow up with your healthcare professional.

Will I experience any side effects?

some women may have changes in their period, such as a period that is heavier or lighter or a period that is early or late. If your period is more than a week late, you may be pregnant.

if you have severe abdominal pain, you may have an ectopic pregnancy, and should get immediate medical attention.
when used as directed, Levonorgestrel Tablet is safe and effective. Side effects may include changes in your period, nausea, lower stomach (abdominal) pain, tiredness, headache, dizziness, and breast tenderness.
if you vomit within 2 hours of taking the medication, call a healthcare professional to find out if you should repeat the dose.

What if I still have questions about Levonorgestrel Tablet?

If you have questions or need more information, call 1-800-224-4606, or visit our website at www.ecpill.com

Other Information

Keep out of reach of children:

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Do not use if the blister seal is opened.

Store at room temperature 20–25°C (68–77°F).

Active ingredient: levonorgestrel 1.5 mg

Inactive ingredients: colloidal silicon dioxide, pregelatinized starch, lactose monohydrate, magnesium stearate, and talc

If you are sexually active, you should see a healthcare provider for routine checkups. Your healthcare provider will talk to you about and, if necessary, test you for sexually transmitted diseases, teach you about effective methods of routine birth control, and answer any other questions you may have.

Manufactured for:

Pharmacist Pharmaceutical, LLC
Salem, VA 24153

PI6223003501

Iss: 03/2014

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Levonorgestrel Tablet, 1.5 mg

NDC 63704-010-01

emergency contraceptive

Reduces chance of pregnancy after unprotected sex.

Not for regular birth control.

Contains 1 Tablet 1.5mg

C:\Users\kvyas\Desktop\spl components\levo-new.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
483325	levonorgestrel 1.5 MG Oral Tablet	PSN	1
483325	levonorgestrel 1.5 MG Oral Tablet	SCD	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LEVONORGESTREL Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20230718

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4d	Product name	7	20190612
f92411e4-13dd-7baf-106e-9b3fcf758c39	Product name	4	20190502
f713a022-3e1c-4035-bc91-62131bc80b42	Product name	2	20190125
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
741e98f2-ac6c-4d80-9ca8-c663c171ba1d	Product name	1	20161121
cc765024-f257-4c67-b780-c356aadd6980	Product name	3	20150902
5a9b579b-8431-5b3a-2ba4-86556704f873	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
d03a75af-b11b-673b-268b-318050d0b3bd	Product name	1	20140508
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508
e5ccd419-1745-560a-1e25-c6e3941c710a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63704-010-01	2019-11-27	C162847	48780-1	9855e2a2-3f6f-60a7-e053-dbdaa90a05bd	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63704-010-01	Levonorgestrel	1 in 1 CARTON	TABLET	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63704-010	LEVONORGESTREL TABLET [PHARMACIST PHARMACEUTICAL, LLC]	1	Legacy NDC, 1 package rows	20140415_20048cf0-9fe6-43f9-8137-4021e5ff910e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63704-010-01	EA - Each	63704-010	f684bd68-d3ba-47eb-a41a-e0037793050d	1	2014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LEVONORGESTREL	ACTIVE INGREDIENT	5W7SIA7YZW	1
LEVONORGESTREL	ACTIVE MOIETY	5W7SIA7YZW	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

Levonorgestrel
SILICON DIOXIDE
STARCH, CORN
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
TALC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63704-010	63704-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LEVONORGESTREL	5W7SIA7YZW	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
TALC	7SEV7J4R1U	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 183 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	PELLET / ORAL		34 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED PELLETS / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, DELAYED RELEASE / ORAL		2313 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / NASAL		20 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, EXTENDED RELEASE / ORAL		5364 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, COATED PELLETS / ORAL		265 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CREAM / VAGINAL		586 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, EXTENDED RELEASE / ORAL		300 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, COATED / ORAL		1301 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER, FOR SUSPENSION / ORAL		735 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	GRANULE, FOR SOLUTION / ORAL	1691.8 mg/120ml		Exact identifier — unii candidate 38 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, COATED, EXTENDED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	CAPSULE, DELAYED RELEASE / ORAL		2087 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE / ORAL		629 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS		174 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET, EXTENDED RELEASE / ORAL		2575 mg	Exact identifier — unii candidate 38 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	POWDER / TOPICAL		9235 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE / ORAL		1190 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE / ORAL		322 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	9.5 %w/v		Exact identifier — unii candidate 38 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	PELLET / ORAL		69 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates

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
A202508-001	LEVONORGESTREL	LEVONORGESTREL	1.5MG	TABLET / ORAL			2013-02-22

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	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202508-001	LEVONORGESTREL	1.5MG	TABLET / ORAL	2013-02-22	`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
840a68ff-8ee6-42d1-b371-6310093ec565			20048cf0-9fe6-43f9-8137-4021e5ff910e	2014-04-15	Warnings	Exact identifier spl id: 840a68ff-8ee6-42d1-b371-6310093ec565 spl set id: 20048cf0-9fe6-43f9-8137-4021e5ff910e

Reported adverse events (FAERS/openFDA)#

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