Lansoprazole
- Product NDC
- 64679-670
- 11-digit product format
- 646790670
- Labeler code
- 64679
- Product ID
- 64679-670_98758247-18f8-49d3-b4a6-3018286179c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Wockhardt USA LLC.
- Application
- ANDA202176
- Marketing category
- ANDA
- Marketing start
- 2012-09-14
- Marketing end
- 0000-00-00
- Substance
- LANSOPRAZOLE
- Active strength
- 30 mg/1
- Pharmacologic classes
- Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64679-670-01 | Lansoprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 30 | | 4 |
| 64679-670-02 | Lansoprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 60 | | 4 |
| 64679-670-03 | Lansoprazole | 100 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 100 | | 4 |
| 64679-670-04 | Lansoprazole | 500 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 500 | | 4 |
| 64679-670-05 | Lansoprazole | 1000 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 1000 | | 4 |
| 64679-670-06 | Lansoprazole | 10 in 1 BLISTER PACK | CAPSULE, DELAYED RELEASE | 10 | | 4 |
| 64679-670-06 | Lansoprazole | 10 in 1 CARTON | CAPSULE, DELAYED RELEASE | 10 | | 4 |
| 64679-670-07 | Lansoprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE | 90 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LANSOPRAZOLE | ACTIVE INGREDIENT | 0K5C5T2QPG | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| LANSOPRAZOLE | ACTIVE MOIETY | 0K5C5T2QPG | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| MAGNESIUM CARBONATE | INACTIVE INGREDIENT | 0E53J927NA | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) | INACTIVE INGREDIENT | 74G4R6TH13 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64679-670 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE [WOCKHARDT USA LLC.] | 4 | Legacy NDC, 8 package rows | 20191127_47e4ed50-56d0-4682-addf-1dcb3fb203ee.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 |
|---|
| 64679-670-01 | 64679067001 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64679-670-01) | | 2012-09-14 | 0000-00-00 | No | No | Current |
| 64679-670-02 | 64679067002 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64679-670-02) | | 2012-09-14 | 0000-00-00 | No | No | Current |
| 64679-670-03 | 64679067003 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64679-670-03) | | 2012-09-14 | 0000-00-00 | No | No | Current |
| 64679-670-04 | 64679067004 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64679-670-04) | | 2012-09-14 | 0000-00-00 | No | No | Current |
| 64679-670-05 | 64679067005 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64679-670-05) | | 2012-09-14 | 0000-00-00 | No | No | Current |
| 64679-670-06 | 64679067006 | 10 BLISTER PACK in 1 CARTON (64679-670-06) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | 10 blister pack | 2012-09-14 | 0000-00-00 | No | No | Current |
| 64679-670-07 | 64679067007 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64679-670-07) | | 2012-09-14 | 0000-00-00 | No | No | Current |