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 02:55:57

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50458-655-30EA - Each50458-655e26cfadd-e80f-4d71-87e5-ab4221bb5eea12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50458-65550458-655-30

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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021692-001ULTRAM ERTRAMADOL HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08
N021692-002ULTRAM ERTRAMADOL HYDROCHLORIDE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08
N021692-003ULTRAM ERTRAMADOL HYDROCHLORIDE300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-0884e616aacf4f…
2026-09-14 22:38:342026-08N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-0884e616aacf4f…
2026-09-14 22:38:342026-08N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-0884e616aacf4f…
2026-08-18 06:07:402026-07N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08caaa826d4ba7…
2026-08-18 06:07:402026-07N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08caaa826d4ba7…
2026-08-18 06:07:402026-07N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-085bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08d06236e962d9…
2024-10-29 15:01 UTC2024-10N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021692-002ULTRAM ER200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-0879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021692-003ULTRAM ER300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021692-001ULTRAM ER100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2005-09-08301d65b070ca…

Reported adverse events (FAERS/openFDA)#

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