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 01:34:18

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-220-28EA - Each43598-2203d5be574-acff-4e3a-8e9f-24c8defd9e5212012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43598-22043598-220-28

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050785-001AUGMENTIN XRAMOXICILLIN; CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALABRLD2002-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N050785-001AB

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALABRLD2002-09-2584e616aacf4f…
2026-08-18 06:07:402026-07N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALABRLD2002-09-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALABRLD2002-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2002-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2002-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2002-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2002-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2002-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2002-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD2002-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2002-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-2587673890dc5c…
2021-03-12 10:30 UTC2021-03N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2002-09-253f01610625f2…
2019-09-15 20:21 UTC2019-09N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2002-09-25b00525d2431f…
2019-07-19 19:46 UTC2019-07N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2002-09-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-253f0d92c62455…
2023-05-13 08:27 UTC2023-05N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-25053a50430f4f…
2023-01-26 05:58 UTC2023-01N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N050785-001AUGMENTIN XR1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRLD2002-09-25f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N050785-001AB184e616aacf4f…
2026-08-18 06:07:402026-07N050785-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N050785-001AB1011fe1cb6892…
2019-12-13 00:20 UTC2019-12N050785-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12N050785-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N050785-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N050785-001AB1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050785-001AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N050785-00167466922020-04-04Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050785-00167837732020-04-04Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050785-00168783862020-04-04U-92674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050785-00172174302020-04-04U-926Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050785-00172501762020-04-04U-92674a2ff9319b5…
2020-12-22 03:56 UTC2020-12N050785-00167466922020-04-04Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050785-00167837732020-04-04Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050785-00168783862020-04-04U-9268869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050785-00172174302020-04-04U-926Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050785-00172501762020-04-04U-9268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050785-00167466922020-04-04Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N050785-00167837732020-04-04Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N050785-00168783862020-04-04U-926c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050785-00172174302020-04-04U-926Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N050785-00172501762020-04-04U-926c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050785-00167466922020-04-04Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N050785-00167837732020-04-04Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N050785-00168783862020-04-04U-9263f01610625f2…
2019-12-14 00:12 UTC2019-12N050785-00172174302020-04-04U-926Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N050785-00172501762020-04-04U-9263f01610625f2…
2019-09-15 20:21 UTC2019-09N050785-00167466922020-04-04Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N050785-00167837732020-04-04Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N050785-00168783862020-04-04U-926b00525d2431f…
2019-09-15 20:21 UTC2019-09N050785-00172174302020-04-04U-926Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N050785-00172501762020-04-04U-926b00525d2431f…
2019-07-19 19:46 UTC2019-07N050785-00167466922020-04-04Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N050785-00167837732020-04-04Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N050785-00168783862020-04-04U-926ea99ee380514…
2019-07-19 19:46 UTC2019-07N050785-00172174302020-04-04U-926Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N050785-00172501762020-04-04U-926ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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