lansoprazole

Product NDC
63629-5632
Requested package NDC
63629-5632-5
11-digit product format
636295632
Labeler code
63629
Product ID
63629-5632_acdb9712-1d1a-4b34-988e-6b4cbb8df9e2
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
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-563263629-5632-5DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202366-001LANSOPRAZOLELANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19
A202366-002LANSOPRAZOLELANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202366-001AB
A202366-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202366-001LANSOPRAZOLE15MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202366-002LANSOPRAZOLE30MGCAPSULE, DELAYED REL PELLETS / ORALAB2013-08-19bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202366-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202366-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202366-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202366-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202366-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202366-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202366-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202366-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202366-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202366-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202366-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202366-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202366-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202366-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202366-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202366-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202366-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202366-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202366-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202366-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202366-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202366-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202366-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202366-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202366-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202366-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202366-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202366-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202366-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202366-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202366-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202366-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202366-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202366-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202366-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202366-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202366-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202366-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202366-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202366-002AB1bb7c543d1eb4…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5632-1EA - Each63629-563256e0a067-49cd-422b-9113-65e392bee13812022-04-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANSOPRAZOLEACTIVE INGREDIENT0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
LANSOPRAZOLEACTIVE MOIETY0K5C5T2QPGLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
ALCOHOLINACTIVE INGREDIENT3K9958V90MLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
AMMONIAINACTIVE INGREDIENT5138Q19F1XLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NALANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ALANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
SHELLACINACTIVE INGREDIENT46N107B71OLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
SUCROSEINACTIVE INGREDIENTC151H8M554LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1ULANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000
WATERINACTIVE INGREDIENT059QF0KO0RLANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]1000

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-5632-56362956320528 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63629-5632-5) 2022-02-080000-00-00NoNoCurrent