Lansoprazole Delayed Release Capsules USP

Manufacturer: Dr. Reddy's Laboratories Limited | Dr.Reddy's Laboratories Limited (FTO III)
Effective date: 2026-07-09
Label type: HUMAN OTC DRUG LABEL
Version: 13
Source: daily-update
Hydrated at: 2026-07-28 05:10:10

Label at a glance#

ProductLansoprazole

Active ingredientLansoprazole

Label structure12 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 days swallow whole. Do not crush or che...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-375-3784

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Lansoprazole USP, 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 healthcare 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 days
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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue No. 2, gelatin, hydroxypropyl cellulose, iron oxide black, iron oxide red, iron oxide yellow, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate 80, sodium lauryl sulphate, starch (corn), sucrose, sugar spheres, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

call 1-888-375-3784

SPL UNCLASSIFIED SECTION

Consumer Information

Lansoprazole Delayed-Release Capsules USP, 15 mg / Acid Reducer

• Treats Frequent Heartburn

• May take 1 to 4 days for full effect

Please read the entire package insert before taking Lansoprazole Delayed-Release Capsules USP, 15 mg. Save for future reference.

How Lansoprazole Delayed-Release Capsules USP, 15 mg Treat Your Frequent Heartburn

Lansoprazole Delayed-Release Capsules USP, 15 mg stops acid production at the source - the pumps that release acid into the stomach. Lansoprazole Delayed-Release Capsules USP, 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 USP, 15 mg

Frequent heartburn can occur anytime during the 24-hour period (day or night). Take Lansoprazole Delayed-Release Capsules USP, 15 mg in the morning before eating. Lansoprazole Delayed-Release Capsules USP, 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 USP, 15 mg every day for 14 days to treat your frequent heartburn.

Who Should Take Lansoprazole Delayed-Release Capsules USP, 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 USP, 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 USP, 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 USP, 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 USP, 15 mg effectively treat frequent heartburn

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

How Lansoprazole Delayed-Release Capsules USP, 15 mg is Sold

Lansoprazole Delayed-Release Capsules USP, 15 mg are 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 USP, 15 mg

Call 1-888-375-3784

Manufactured by:

Dr. Reddy's Laboratories Limited

Bachupally - 500 090 INDIA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container : 14's count

container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container carton : 14's count

containercarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
d6b97638-59f4-48e2-8959-569628732c46	Product name	9	20210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Lansoprazole	ACTIVE INGREDIENT	0K5C5T2QPG	7
Lansoprazole	ACTIVE MOIETY	0K5C5T2QPG	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	7
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	7
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	7
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	7
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	7
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	7
SUCROSE	INACTIVE INGREDIENT	C151H8M554	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	7

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Lansoprazole
FD&C BLUE NO. 2
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
GELATIN
HYDROXYPROPYL CELLULOSE (110000 WAMW)
FERROSOFERRIC OXIDE
Hydroxypropyl Cellulose, Low Substituted
MAGNESIUM CARBONATE
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
POLYETHYLENE GLYCOL 6000
POLYSORBATE 80
SODIUM LAURYL SULFATE
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55111-739	55111-739-52, 55111-739-27, 55111-739-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Lansoprazole	0K5C5T2QPG	ACTIB
FD&C BLUE NO. 2	L06K8R7DQK	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
GELATIN	2G86QN327L	IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)	5Y0974F5PW	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
Hydroxypropyl Cellulose, Low Substituted	2165RE0K14	IACT
MAGNESIUM CARBONATE	0E53J927NA	IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
STARCH, CORN	O8232NY3SJ	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
12	2025-07-03	full-release	2026-06-01 01:06:27

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 2 · 76 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, FILM COATED / ORAL		40 mg	Exact identifier — unii+route 16 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, FILM COATED / ORAL		40 mg	Exact identifier — unii+route 16 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET / ORAL		480 mg	Exact identifier — unii+route 16 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, DELAYED RELEASE / ORAL		103 mg	Exact identifier — unii+route 16 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM CARBONATE	MAGNESIUM CARBONATE	0E53J927NA	CAPSULE, DELAYED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, FILM COATED / ORAL		40 mg	Exact identifier — unii+route 16 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	CAPSULE, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	CAPSULE, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET / ORAL		480 mg	Exact identifier — unii+route 16 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	CAPSULE, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM CARBONATE	MAGNESIUM CARBONATE	0E53J927NA	CAPSULE, DELAYED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	CAPSULE, DELAYED RELEASE / ORAL		150 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	CAPSULE, DELAYED RELEASE / ORAL		1321 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	CAPSULE / ORAL		150 mg	Exact identifier — unii+route 16 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE, DELAYED RELEASE / ORAL	0.22 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	CAPSULE, DELAYED RELEASE / ORAL		35 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	CAPSULE / ORAL		150 mg	Exact identifier — unii+route 16 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	CAPSULE, DELAYED RELEASE / ORAL		150 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	CAPSULE, DELAYED RELEASE / ORAL		1321 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	CAPSULE, DELAYED RELEASE / ORAL		14 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MAGNESIUM CARBONATE	MAGNESIUM CARBONATE	0E53J927NA	CAPSULE, DELAYED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	CAPSULE, DELAYED RELEASE / ORAL		1321 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	CAPSULE, DELAYED RELEASE / ORAL		150 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	CAPSULE / ORAL		150 mg	Exact identifier — unii+route 16 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE, DELAYED RELEASE / ORAL	0.22 mg		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	NX76LV5T8J	CAPSULE, DELAYED RELEASE / ORAL		1321 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE / ORAL		46 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	CAPSULE, DELAYED RELEASE / ORAL		420 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	CAPSULE / ORAL		150 mg	Exact identifier — unii+route 16 equally ranked IID candidates
MAGNESIUM CARBONATE	MAGNESIUM CARBONATE	0E53J927NA	CAPSULE, DELAYED RELEASE / ORAL		180 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, DELAYED RELEASE / ORAL		103 mg	Exact identifier — unii+route 16 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, DELAYED RELEASE / ORAL		103 mg	Exact identifier — unii+route 16 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, DELAYED RELEASE / ORAL		103 mg	Exact identifier — unii+route 16 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE	2165RE0K14	TABLET, FILM COATED / ORAL		40 mg	Exact identifier — unii+route 16 equally ranked IID candidates
FERRIC OXIDE YELLOW	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE, DELAYED RELEASE / ORAL	0.22 mg		Exact identifier — unii+route+dosage form 4 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
A202194-001	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	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202194-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	2012-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202194-001	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
Lansoprazole	LANSOPRAZOLE	Dr. Reddy's Laboratories Limited	15e05eda-48aa-a4b7-4b8a-4ee1cf110120	2026-07-09	Warnings	Exact identifier ndc (package): 55111-739-33 ndc (package): 55111-739-27 ndc (package): 55111-739-52 ndc (product): 55111-739 ndc11 (package): 55111073933 ndc11 (package): 55111073952 ndc11 (package): 55111073927 spl id: 06355b28-9bb0-baea-0f4b-f1e4f7e670b6 spl set id: 15e05eda-48aa-a4b7-4b8a-4ee1cf110120

Reported adverse events (FAERS/openFDA)#

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