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 01:57:03

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0237-63ML - Milliliter0054-02376744e424-d866-41db-afc2-2bf8bb201ac212012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0054-02370054-0237-63

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
N022195-001MORPHINE SULFATEMORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-17
N022195-002MORPHINE SULFATEMORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-17
N022195-003MORPHINE SULFATEMORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N022195-001AA
N022195-002AA
N022195-003AA

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 22:38:342026-08N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-1784e616aacf4f…
2026-09-14 22:38:342026-08N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-1784e616aacf4f…
2026-09-14 22:38:342026-08N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-2584e616aacf4f…
2026-08-18 06:07:402026-07N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALRLD2008-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022195-002MORPHINE SULFATE20MG/5MLSOLUTION / ORALAARLD2008-03-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022195-003MORPHINE SULFATE100MG/5MLSOLUTION / ORALAARLD, RS2010-01-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022195-001MORPHINE SULFATE10MG/5MLSOLUTION / ORALAARLD2008-03-17301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N022195-001AA184e616aacf4f…
2026-09-14 22:38:342026-08N022195-002AA184e616aacf4f…
2026-09-14 22:38:342026-08N022195-003AA184e616aacf4f…
2026-08-18 06:07:402026-07N022195-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07N022195-002AA1caaa826d4ba7…
2026-08-18 06:07:402026-07N022195-003AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022195-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022195-002AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022195-003AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022195-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022195-002AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022195-003AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022195-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022195-002AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022195-003AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022195-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022195-003AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022195-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022195-002AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022195-003AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022195-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022195-002AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022195-003AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022195-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022195-002AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022195-003AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022195-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022195-002AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022195-003AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022195-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022195-002AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022195-003AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022195-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022195-002AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022195-003AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022195-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022195-002AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022195-003AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022195-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022195-002AA1301d65b070ca…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022195-001NPP2024-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022195-002NPP2024-06-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022195-001NPP2024-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022195-002NPP2024-06-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022195-001NPP2024-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022195-002NPP2024-06-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022195-001NPP2024-06-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022195-002NPP2024-06-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022195-001NPP2024-06-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N022195-002NPP2024-06-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022195-001NPP2024-06-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022195-002NPP2024-06-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022195-001NPP2024-06-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022195-002NPP2024-06-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022195-001NPP2024-06-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022195-002NPP2024-06-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022195-001NPP2024-06-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022195-002NPP2024-06-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022195-001NPP2024-06-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022195-002NPP2024-06-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022195-001NPP2024-06-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022195-002NPP2024-06-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022195-001NPP2024-06-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022195-002NPP2024-06-024b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N022195-001NPP2024-06-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022195-002NPP2024-06-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022195-001NPP2024-06-02782e0a99824c…
2021-12-28 21:50 UTC2021-12N022195-002NPP2024-06-02782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022195-001NPP2024-06-026a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022195-002NPP2024-06-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022195-001NPP2024-06-021c564ffb4f44…
2024-02-18 07:12 UTC2024-02N022195-002NPP2024-06-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022195-001NPP2024-06-02ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N022195-002NPP2024-06-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022195-001NPP2024-06-02a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022195-002NPP2024-06-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022195-001NPP2024-06-029b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022195-002NPP2024-06-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022195-001NPP2024-06-02a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022195-002NPP2024-06-02a67488948f0b…

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
Morphine SulfateMORPHINE SULFATEHikma Pharmaceuticals USA Inc.ca359246-4674-4b32-b8b2-673d32b7112f2026-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 0054-0237-63
ndc11 (package): 00054023763

Reported adverse events (FAERS/openFDA)#

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