lansoprazole
- Product NDC
- 63629-7552
- 11-digit product format
- 636297552
- Labeler code
- 63629
- Product ID
- 63629-7552_b5b4da2d-77d7-455b-b874-0f679a5c50dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lansoprazole
- Dosage form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA202366
- Marketing category
- ANDA
- Marketing start
- 2013-08-23
- Substance
- LANSOPRAZOLE
- Active strength
- 30 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0K5C5T2QPG |
| Rxcui | 311277 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 63629-7552-1 | 2021-12-30 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-2 | 2021-12-30 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-3 | 2021-12-30 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-4 | 2021-12-30 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-5 | 2021-12-30 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-6 | 2021-12-30 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-7 | 2021-12-30 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-8 | 2021-12-30 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-9 | 2021-12-30 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-7 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-8 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
| 63629-7552-9 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a192-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1995 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-7552-1 | lansoprazole | 30 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 30 | | 6 |
| 63629-7552-2 | lansoprazole | 90 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 90 | | 6 |
| 63629-7552-3 | lansoprazole | 18 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 18 | | 6 |
| 63629-7552-4 | lansoprazole | 28 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 28 | | 6 |
| 63629-7552-5 | lansoprazole | 56 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 56 | | 6 |
| 63629-7552-6 | lansoprazole | 58 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 58 | | 6 |
| 63629-7552-7 | lansoprazole | 60 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 60 | | 6 |
| 63629-7552-8 | lansoprazole | 180 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 180 | | 6 |
| 63629-7552-9 | lansoprazole | 120 in 1 BOTTLE | CAPSULE, DELAYED RELEASE PELLETS | 120 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-7552 | LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK] | 6 | Current NDC, Legacy NDC, 9 package rows | 20241205_dbcd423f-91fe-4a06-bf31-9e01ad68b7b0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-7552-1 | 63629755201 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-7552-1) | 2018-03-12 | 0000-00-00 | No | No | Current |
| 63629-7552-2 | 63629755202 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-7552-2) | 2018-03-08 | 0000-00-00 | No | No | Current |
| 63629-7552-3 | 63629755203 | 18 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-7552-3) | 2021-12-09 | 0000-00-00 | No | No | Current |
| 63629-7552-4 | 63629755204 | 28 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-7552-4) | 2021-12-09 | 0000-00-00 | No | No | Current |
| 63629-7552-5 | 63629755205 | 56 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-7552-5) | 2021-12-09 | 0000-00-00 | No | No | Current |
| 63629-7552-6 | 63629755206 | 58 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-7552-6) | 2021-12-09 | 0000-00-00 | No | No | Current |
| 63629-7552-7 | 63629755207 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-7552-7) | 2018-04-26 | 0000-00-00 | No | No | Current |
| 63629-7552-8 | 63629755208 | 180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-7552-8) | 2021-12-09 | 0000-00-00 | No | No | Current |
| 63629-7552-9 | 63629755209 | 120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-7552-9) | 2021-12-09 | 0000-00-00 | No | No | Current |