lansoprazole

Manufacturer: Publix Super Markets Inc
Effective date: 2020-04-14
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 23:07:10

Label at a glance#

Productlansoprazole

Active ingredientLANSOPRAZOLE

Label structure7 sections

Dosage and administration

• adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment • swallow 1 capsule with a glass of water before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • swallow whole. Do not...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-719-9260

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Lansoprazole 15 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Use

INDICATIONS & USAGE SECTION

treats frequent heartburn (occurs 2 or more days a week)
not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to lansoprazole

Do not use

OTC - DO NOT USE SECTION

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

liver disease
had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

your heartburn continues or worsens
you need to take this product for more than 14 days
you need to take more than 1 course of treatment every 4 months
you get diarrhea
you develop a rash or joint pain

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

adults 18 years of age and older
this product is to be used once a day (every 24 hours), every day for 14 days
it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

swallow 1 capsule with a glass of water before eating in the morning
take every day for 14 days
do not take more than 1 capsule a day
swallow whole. Do not crush or chew capsules.
do not use for more than 14 days unless directed by your doctor

Repeated 14-Day Courses (if needed)

you may repeat a 14-day course every 4 months
do not take for more than 14 days or more often than every 4 months unless directed by a doctor
children under 18 years of age: ask a doctor before use. Heartburn in children may sometimes be caused by a serious condition.

Other information

STORAGE AND HANDLING SECTION

read the directions, warnings and package insert before use
keep the carton and package insert. They contain important information.
store at 68-77°F (20-25°C)
keep product out of high heat and humidity
protect product from moisture
close cap tightly after use

Inactive ingredients

INACTIVE INGREDIENT SECTION

D&C red no. 28, D&C yellow no. 10, FD&C blue no. 1, gelatin, hypromellose, low substituted hydroxypropyl cellulose, mannitol, meglumine, methacrylic acid copolymer, pharmaceutical ink, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide

Consumer Information

SPL UNCLASSIFIED SECTION

Treats Frequent Heartburn

Lansoprazole

Delayed-Release Capsules 15 mg / Acid Reducer

May take 1 to 4 days for full effect
Sodium Free

Please read the entire package insert before taking Lansoprazole Delayed-Release Capsules 15 mg.

Save for future reference.

How Lansoprazole Delayed-Release Capsules 15 mg Treats Your Frequent Heartburn

Lansoprazole Delayed-Release Capsules 15 mg stops acid production at the source – the pumps that release acid into the stomach. Lansoprazole Delayed-Release Capsules 15 mg is taken once a day (every 24 hours), every day for 14 days.

What You Can Expect When Taking Lansoprazole Delayed-Release Capsules 15 mg

Frequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole Delayed-Release Capsules 15 mg in the morning before eating. Lansoprazole Delayed-Release Capsules 15 mg is clinically proven to treat frequent heartburn. Although some people get complete relief of symptoms within 24 hours, it may take 1 to 4 days for full effect. Make sure you take Lansoprazole Delayed-Release Capsules 15 mg every day for 14 days to treat your frequent heartburn.

Who Should Take Lansoprazole Delayed-Release Capsules 15 mg

Adults (18 years and older) with frequent heartburn – when you have heartburn 2 or more days a week.

Who Should NOT Take Lansoprazole Delayed-Release Capsules 15 mg

People who have one episode of heartburn a week or less, or who want immediate relief of heartburn.

How to Take Lansoprazole Delayed-Release Capsules 15 mg

14-DAY Course of Treatment

Swallow 1 capsule with a glass of water before eating in the morning.
Take every day for 14 days.
Do not take more than 1 capsule a day.
Swallow whole. Do not crush or chew capsules.
Do not use for more than 14 days unless directed by your doctor.

When to Take Lansoprazole Delayed-Release Capsules 15 mg Again

You may repeat a 14-day course of therapy every 4 months.

When to Talk to Your Doctor

Do not take for more than 14 days or more often than every 4 months unless directed by a doctor.

Warnings and When to Ask Your Doctor

Allergy alert: Do not use if you are allergic to lansoprazole

Do not use

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

liver disease
had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain

Ask a doctor or pharmacist before use if you are

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Stop use and ask a doctor if

your heartburn continues or worsens
you need to take this product for more than 14 days
you need to take more than 1 course of treatment every 4 months
you get diarrhea
you develop a rash or joint pain

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Tips for Managing Heartburn

Avoid foods or drinks that are more likely to cause heartburn, such as rich, spicy, fatty and fried foods, chocolate, caffeine, alcohol and even some acidic fruits and vegetables.
Eat slowly and do not eat big meals.
Do not eat late at night or just before bedtime.
Do not lie flat or bend over soon after eating.
Raise the head of your bed.
Wear loose-fitting clothing around your stomach.
If you are overweight, lose weight.
If you smoke, quit smoking.

Clinical studies prove Lansoprazole Delayed-Release Capsules 15 mg effectively treats frequent heartburn

In three clinical studies, Lansoprazole Delayed-Release Capsules 15 mg was shown to be significantly better than placebo in treating frequent heartburn.

How Lansoprazole Delayed-Release Capsules 15 mg is Sold

Lansoprazole Delayed-Release Capsules 15 mg is available in 14 capsule, 28 capsule and 42 capsule sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use for more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

For Questions or Comments About Lansoprazole Delayed-Release Capsules 15 mg

Call 1-800-719-9260

Distributed By

Perrigo®

Allegan, MI 49010

: 3T300 00 J6

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

24-HOUR

lansoprazole

DELAYED-RELEASE CAPSULES 15 mg ACID REDUCER

Treats frequent heartburn

May take 1 to 4 days for full effect

Sodium free

Actual Size

42 CAPSULES

THREE-14-DAY COURSES OF TREATMENT

Compare to the active ingredient in Prevacid® 24 HR

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
596843	lansoprazole 15 MG Delayed Release Oral Capsule	PSN	6
596843	lansoprazole 15 MG Delayed Release Oral Capsule	SCD	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LANSOPRAZOLE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d6b97638-59f4-48e2-8959-569628732c46	Product name	9	20210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
56062-117-01	lansoprazole	1 in 1 CARTON	CAPSULE, DELAYED RELEASE	1	6
56062-117-01	lansoprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	6
56062-117-03	lansoprazole	14 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	14	6
56062-117-03	lansoprazole	3 in 1 CARTON	CAPSULE, DELAYED RELEASE	3	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
56062-117	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [PUBLIX SUPER MARKETS INC]	6	Legacy NDC, 4 package rows	20200421_e226a1eb-39c8-440a-9824-1e5ccddc249e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LANSOPRAZOLE	ACTIVE INGREDIENT	0K5C5T2QPG	2
LANSOPRAZOLE	ACTIVE MOIETY	0K5C5T2QPG	2
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	2
MEGLUMINE	INACTIVE INGREDIENT	6HG8UB2MUY	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

lansoprazole
D&C RED NO. 28
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
MANNITOL
MEGLUMINE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
56062-117	56062-117-01, 56062-117-03

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
LANSOPRAZOLE	0K5C5T2QPG	ACTIB
D&C RED NO. 28	767IP0Y5NH	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MANNITOL	3OWL53L36A	IACT
MEGLUMINE	6HG8UB2MUY	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED	2165RE0K14	IACT

Source Document#

Source XML · Source PDF

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 7 · 420 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
TALC	TALC	7SEV7J4R1U	ELIXIR / ORAL	4.5 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / AURICULAR (OTIC)		13 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / ORAL		10932 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
MEGLUMINE	MEGLUMINE	6HG8UB2MUY	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, DELAYED RELEASE PELLETS / ORAL	0.01 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, EXTENDED RELEASE / ORAL		239 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	SHAMPOO / TOPICAL	3 %w/w		Exact identifier — unii candidate 27 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	GRANULE, FOR SUSPENSION / ORAL	1.7 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION/ DROPS / OPHTHALMIC	3.3 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE / ORAL		1488 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAVENOUS		1170 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 37 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	SUSPENSION, EXTENDED RELEASE / ORAL	2464.6 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
MEGLUMINE	MEGLUMINE	6HG8UB2MUY	INJECTION / INTRAMUSCULAR	144.76 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 31 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SYRUP / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, LIQUID FILLED / ORAL		1042 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	MOUTHWASH / BUCCAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LOTION / TOPICAL		326 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL		13 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	35 mg		Exact identifier — unii candidate 65 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	GEL / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 42 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SYRUP / ORAL		4 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SHAMPOO / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	GUM, CHEWING / ORAL		2 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	POWDER, FOR SUSPENSION / INTRAMUSCULAR	6.75 %w/v		Exact identifier — unii candidate 65 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	FILM, SOLUBLE / ORAL	0.04 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE / ORAL	20 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SOFT TISSUE		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SYSTEM / TOPICAL		28 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	JELLY / TOPICAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	PASTE / DENTAL		252 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	SUSPENSION, EXTENDED RELEASE / ORAL	0.08 mg/1ml		Exact identifier — unii candidate 42 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		1568 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS		658 mg	Exact identifier — unii candidate 65 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	LOTION / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	PELLET / ORAL		2 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
MANNITOL	MANNITOL	3OWL53L36A	GUM, CHEWING / BUCCAL		891 mg	Exact identifier — unii candidate 65 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 44.

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
A202319-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL			2012-05-18

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202319-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3a93d1ddd44b…`

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
422f715c-59b5-4146-9729-4ef1ecc608ac			e226a1eb-39c8-440a-9824-1e5ccddc249e	2020-04-14	Warnings	Exact identifier spl id: 422f715c-59b5-4146-9729-4ef1ecc608ac spl set id: e226a1eb-39c8-440a-9824-1e5ccddc249e

Reported adverse events (FAERS/openFDA)#

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