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 02:06:37

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-7206-07GM - Gram0085-72067bf9eccc-ee3a-402d-a16c-b5724bf76aee12012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0085-72060085-7206-07

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
N022518-001DULERAFORMOTEROL FUMARATE; MOMETASONE FUROATE0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22
N022518-002DULERAFORMOTEROL FUMARATE; MOMETASONE FUROATE0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22
N022518-003DULERAFORMOTEROL FUMARATE; MOMETASONE FUROATE0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD, RS2019-08-12

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 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-2284e616aacf4f…
2026-09-14 22:38:342026-08N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-2284e616aacf4f…
2026-09-14 22:38:342026-08N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD, RS2019-08-1284e616aacf4f…
2026-08-18 06:07:402026-07N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22caaa826d4ba7…
2026-08-18 06:07:402026-07N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD, RS2019-08-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD, RS2019-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD, RS2019-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD, RS2019-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD, RS2019-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD, RS2019-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD, RS2019-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD2019-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD2019-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD2019-08-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD2019-08-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022518-002DULERA0.005MG/INH;0.2MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022518-003DULERA0.005MG/INH;0.05MG/INHAEROSOL, METERED / INHALATIONRLD2019-08-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022518-001DULERA0.005MG/INH;0.1MG/INHAEROSOL, METERED / INHALATIONRLD, RS2010-06-22301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N022518-00170675022020-05-21U-1068Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022518-00175667052020-05-21U-1068Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022518-0017067502*PED2020-11-21Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022518-0017566705*PED2020-11-21Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022518-00270675022020-05-21U-1068Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022518-00275667052020-05-21U-1068Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022518-0027067502*PED2020-11-21Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022518-0027566705*PED2020-11-21Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N022518-00170675022020-05-21U-1068Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022518-00175667052020-05-21U-1068Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022518-0017067502*PED2020-11-21Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022518-0017566705*PED2020-11-21Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022518-00270675022020-05-21U-1068Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022518-00275667052020-05-21U-1068Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022518-0027067502*PED2020-11-21Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022518-0027566705*PED2020-11-21Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022518-00170675022020-05-21U-1068Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022518-00175667052020-05-21U-1068Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022518-0017067502*PED2020-11-21Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022518-0017566705*PED2020-11-21Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022518-00270675022020-05-21U-1068Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022518-00275667052020-05-21U-1068Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022518-0027067502*PED2020-11-21Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022518-0027566705*PED2020-11-21Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N022518-00170675022020-05-21U-1068Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N022518-00175667052020-05-21U-1068Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N022518-0017067502*PED2020-11-21Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N022518-0017566705*PED2020-11-21Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N022518-00270675022020-05-21U-1068Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N022518-00275667052020-05-21U-1068Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N022518-0027067502*PED2020-11-21Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N022518-0027566705*PED2020-11-21Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N022518-00170675022020-05-21U-1068Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N022518-00175667052020-05-21U-1068Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N022518-0017067502*PED2020-11-21Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N022518-0017566705*PED2020-11-21Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N022518-00270675022020-05-21U-1068Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N022518-00275667052020-05-21U-1068Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N022518-0027067502*PED2020-11-21Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N022518-0027566705*PED2020-11-21Pediatric extensionb00525d2431f…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022518-003NS2022-08-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022518-003PED2023-02-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022518-003NS2022-08-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022518-003PED2023-02-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022518-003NS2022-08-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022518-003PED2023-02-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022518-001M-2142020-12-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022518-001PED2021-06-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022518-002M-2142020-12-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022518-002PED2021-06-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022518-003NS2022-08-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022518-003PED2023-02-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022518-001PED2021-06-20782e0a99824c…
2021-12-28 21:50 UTC2021-12N022518-002PED2021-06-20782e0a99824c…
2021-12-28 21:50 UTC2021-12N022518-003NS2022-08-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N022518-003PED2023-02-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022518-001PED2021-06-2087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022518-002PED2021-06-2087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022518-003NS2022-08-1287673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022518-003PED2023-02-1287673890dc5c…
2021-03-12 10:30 UTC2021-03N022518-001PED2021-06-205aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022518-002PED2021-06-205aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022518-003NS2022-08-125aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022518-003PED2023-02-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022518-001M-2142020-12-208869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022518-001PED2021-06-208869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022518-002M-2142020-12-208869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022518-002PED2021-06-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022518-001M-2142020-12-20c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022518-001PED2021-06-20c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022518-002M-2142020-12-20c0c555d07b60…
2020-11-12 02:37 UTC2020-11N022518-002PED2021-06-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022518-001M-2142020-12-203f01610625f2…
2019-12-14 00:12 UTC2019-12N022518-001PED2021-06-203f01610625f2…
2019-12-14 00:12 UTC2019-12N022518-002M-2142020-12-203f01610625f2…
2019-12-14 00:12 UTC2019-12N022518-002PED2021-06-203f01610625f2…
2019-09-15 20:21 UTC2019-09N022518-001M-2142020-12-20b00525d2431f…
2019-09-15 20:21 UTC2019-09N022518-001PED2021-06-20b00525d2431f…
2019-09-15 20:21 UTC2019-09N022518-002M-2142020-12-20b00525d2431f…
2019-09-15 20:21 UTC2019-09N022518-002PED2021-06-20b00525d2431f…

Reported adverse events (FAERS/openFDA)#

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