Lansoprazole
- Product NDC
- 55111-739
- 11-digit product format
- 551110739
- Labeler code
- 55111
- Product ID
- 55111-739_54f62b79-6b37-f219-d8da-1f9f55d1b203
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Limited
- Application
- ANDA202194
- Marketing category
- ANDA
- Marketing start
- 2019-08-19
- Substance
- LANSOPRAZOLE
- Active strength
- 15 mg/1
- Pharmacologic classes
- Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lansoprazole
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LANSOPRAZOLE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K5C5T2QPG |
| Rxcui | 596843 |
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Lansoprazole | ACTIVE INGREDIENT | 0K5C5T2QPG | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| Lansoprazole | ACTIVE MOIETY | 0K5C5T2QPG | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| MAGNESIUM CARBONATE | INACTIVE INGREDIENT | 0E53J927NA | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A | INACTIVE INGREDIENT | NX76LV5T8J | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-739 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED] | 11 | Current NDC, Legacy NDC | 20190819_15e05eda-48aa-a4b7-4b8a-4ee1cf110120.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55111-739-27 | 55111073927 | 2 BOTTLE in 1 CARTON (55111-739-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 2 bottle | 2019-08-19 | 0000-00-00 | No | No | Current |
| 55111-739-33 | 55111073933 | 3 BOTTLE in 1 CARTON (55111-739-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 3 bottle | 2019-08-19 | 0000-00-00 | No | No | Current |
| 55111-739-48 | 55111073948 | 12 POUCH in 1 CASE (55111-739-48) / 4000 CAPSULE, DELAYED RELEASE in 1 POUCH (55111-739-94) | 12 pouch | 18-MAY-22 | | | | Current |
| 55111-739-52 | 55111073952 | 1 BOTTLE in 1 CARTON (55111-739-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE | 1 bottle | 2019-08-19 | 0000-00-00 | No | No | Current |