National Council for Prescription Drug Programs indexing - billing unit

Manufacturer
National Council for Prescription Drug Programs
Effective date
2012-07-24
Label type
Indexing - Billing Unit
Version
1
Source
full-release
Hydrated at
2026-06-05 02:29:51

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54092-252-45EA - Each54092-252b282d18a-0ea6-49f4-9604-90f1f1568bc412012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54092-25254092-252-45

Source Document#

Source XML

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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021468-001FOSRENOLLANTHANUM CARBONATEEQ 250MG BASETABLET, CHEWABLE / ORAL2004-10-26
N021468-002FOSRENOLLANTHANUM CARBONATEEQ 500MG BASETABLET, CHEWABLE / ORALABRLD2004-10-26
N021468-003FOSRENOLLANTHANUM CARBONATEEQ 750MG BASETABLET, CHEWABLE / ORALABRLD2005-11-23
N021468-004FOSRENOLLANTHANUM CARBONATEEQ 1GM BASETABLET, CHEWABLE / ORALABRLD, RS2005-11-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N021468-002AB
N021468-003AB
N021468-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021468-001FOSRENOLEQ 250MG BASETABLET, CHEWABLE / ORAL2004-10-2684e616aacf4f…
2026-09-14 22:38:342026-08N021468-002FOSRENOLEQ 500MG BASETABLET, CHEWABLE / ORALABRLD2004-10-2684e616aacf4f…
2026-09-14 22:38:342026-08N021468-003FOSRENOLEQ 750MG BASETABLET, CHEWABLE / ORALABRLD2005-11-2384e616aacf4f…
2026-09-14 22:38:342026-08N021468-004FOSRENOLEQ 1GM BASETABLET, CHEWABLE / ORALABRLD, RS2005-11-2384e616aacf4f…
2026-08-18 06:07:402026-07N021468-001FOSRENOLEQ 250MG BASETABLET, CHEWABLE / ORAL2004-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N021468-002FOSRENOLEQ 500MG BASETABLET, CHEWABLE / ORALABRLD2004-10-26caaa826d4ba7…
2026-08-18 06:07:402026-07N021468-003FOSRENOLEQ 750MG BASETABLET, CHEWABLE / ORALABRLD2005-11-23caaa826d4ba7…
2026-08-18 06:07:402026-07N021468-004FOSRENOLEQ 1GM BASETABLET, CHEWABLE / ORALABRLD, RS2005-11-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021468-001FOSRENOLEQ 250MG BASETABLET, CHEWABLE / ORAL2004-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021468-002FOSRENOLEQ 500MG BASETABLET, CHEWABLE / ORALABRLD2004-10-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021468-003FOSRENOLEQ 750MG BASETABLET, CHEWABLE / ORALABRLD2005-11-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021468-004FOSRENOLEQ 1GM BASETABLET, CHEWABLE / ORALABRLD, RS2005-11-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021468-001FOSRENOLEQ 250MG BASETABLET, CHEWABLE / ORAL2004-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021468-002FOSRENOLEQ 500MG BASETABLET, CHEWABLE / ORALABRLD2004-10-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021468-003FOSRENOLEQ 750MG BASETABLET, CHEWABLE / ORALABRLD2005-11-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021468-004FOSRENOLEQ 1GM BASETABLET, CHEWABLE / ORALABRLD, RS2005-11-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N021468-001FOSRENOLEQ 250MG BASETABLET, CHEWABLE / ORAL2004-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021468-002FOSRENOLEQ 500MG BASETABLET, CHEWABLE / ORALABRLD2004-10-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021468-003FOSRENOLEQ 750MG BASETABLET, CHEWABLE / ORALABRLD2005-11-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021468-004FOSRENOLEQ 1GM BASETABLET, CHEWABLE / ORALABRLD, RS2005-11-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021468-001FOSRENOLEQ 250MG BASETABLET, CHEWABLE / ORAL2004-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021468-002FOSRENOLEQ 500MG BASETABLET, CHEWABLE / ORALABRLD2004-10-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021468-003FOSRENOLEQ 750MG BASETABLET, CHEWABLE / ORALABRLD2005-11-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021468-004FOSRENOLEQ 1GM BASETABLET, CHEWABLE / ORALABRLD, RS2005-11-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021468-001FOSRENOLEQ 250MG BASETABLET, CHEWABLE / ORAL2004-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021468-002FOSRENOLEQ 500MG BASETABLET, CHEWABLE / ORALABRLD2004-10-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021468-003FOSRENOLEQ 750MG BASETABLET, CHEWABLE / ORALABRLD2005-11-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021468-004FOSRENOLEQ 1GM BASETABLET, CHEWABLE / ORALABRLD, RS2005-11-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-001FOSRENOLEQ 250MG BASETABLET, CHEWABLE / ORAL2004-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-002FOSRENOLEQ 500MG BASETABLET, CHEWABLE / ORALABRLD2004-10-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-003FOSRENOLEQ 750MG BASETABLET, CHEWABLE / ORALABRLD2005-11-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-004FOSRENOLEQ 1GM BASETABLET, CHEWABLE / ORALABRLD, RS2005-11-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-001FOSRENOLEQ 250MG BASETABLET, CHEWABLE / ORAL2004-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-002FOSRENOLEQ 500MG BASETABLET, CHEWABLE / ORALABRLD2004-10-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-003FOSRENOLEQ 750MG BASETABLET, CHEWABLE / ORALABRLD2005-11-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-004FOSRENOLEQ 1GM BASETABLET, CHEWABLE / ORALABRLD, RS2005-11-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-001FOSRENOLEQ 250MG BASETABLET, CHEWABLE / ORAL2004-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-002FOSRENOLEQ 500MG BASETABLET, CHEWABLE / ORALABRLD2004-10-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-003FOSRENOLEQ 750MG BASETABLET, CHEWABLE / ORALABRLD2005-11-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-004FOSRENOLEQ 1GM BASETABLET, CHEWABLE / ORALABRLD, RS2005-11-235bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021468-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N021468-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N021468-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N021468-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021468-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021468-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021468-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021468-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021468-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021468-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021468-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021468-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021468-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021468-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021468-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021468-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021468-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021468-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021468-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021468-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021468-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021468-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021468-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021468-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021468-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021468-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021468-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021468-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021468-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021468-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021468-002AB1301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 7 · 280 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-00173814282024-08-26U-89003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-00174654652024-08-26Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-00273814282024-08-26U-89003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-00274654652024-08-26Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-00373814282024-08-26U-89003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-00374654652024-08-26Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-00473814282024-08-26U-89003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021468-00474654652024-08-26Drug product03ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-00173814282024-08-26U-8902680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-00174654652024-08-26Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-00273814282024-08-26U-8902680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-00274654652024-08-26Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-00373814282024-08-26U-8902680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-00374654652024-08-26Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-00473814282024-08-26U-8902680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021468-00474654652024-08-26Drug product2680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-00173814282024-08-26U-8905bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-00174654652024-08-26Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-00273814282024-08-26U-8905bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-00274654652024-08-26Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-00373814282024-08-26U-8905bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-00374654652024-08-26Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-00473814282024-08-26U-8905bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021468-00474654652024-08-26Drug product5bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021468-00173814282024-08-26U-890d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021468-00174654652024-08-26Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021468-00273814282024-08-26U-890d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021468-00274654652024-08-26Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021468-00373814282024-08-26U-890d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021468-00374654652024-08-26Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021468-00473814282024-08-26U-890d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021468-00474654652024-08-26Drug productd8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021468-00173814282024-08-26U-890d06236e962d9…
2024-10-29 15:01 UTC2024-10N021468-00174654652024-08-26Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N021468-00273814282024-08-26U-890d06236e962d9…
2024-10-29 15:01 UTC2024-10N021468-00274654652024-08-26Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N021468-00373814282024-08-26U-890d06236e962d9…
2024-10-29 15:01 UTC2024-10N021468-00374654652024-08-26Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N021468-00473814282024-08-26U-890d06236e962d9…
2024-10-29 15:01 UTC2024-10N021468-00474654652024-08-26Drug productd06236e962d9…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FosrenolLANTHANUM CARBONATETakeda Pharmaceuticals America, Inc.f10776b2-2c25-4343-aabe-68f302e5cb542024-12-31Warnings, Adverse reactionsExact identifier
ndc (package): 54092-252-45
ndc11 (package): 54092025245

Reported adverse events (FAERS/openFDA)#

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