Home NDC 0409-2022 Morphine sulfate
Product NDC 0409-2022
11-digit product format 004092022
Labeler code 0409
Product ID 0409-2022_6f2d5741-5543-4bea-8d1d-7e4889b634a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA202515
Marketing category NDA
Marketing start 2025-04-21
Substance MORPHINE SULFATE
Active strength 50 mg/mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 20 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0409-2022-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0409-2022-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0409-2022-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0409-2022-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0409-2022-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0409-2022-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0409-2022-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0409-2022-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0409-2022-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0409-2022-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202515-001 MORPHINE SULFATE MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 N202515-002 MORPHINE SULFATE MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 N202515-003 MORPHINE SULFATE MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 N202515-004 MORPHINE SULFATE MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 N202515-005 MORPHINE SULFATE MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 N202515-006 MORPHINE SULFATE MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 7 · 244 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202515-005 MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202515-006 MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202515-005 MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202515-006 MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202515-005 MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202515-006 MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202515-005 MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202515-006 MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202515-005 MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202515-006 MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202515-005 MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202515-006 MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD, RS 2021-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202515-001 MORPHINE SULFATE 2MG/ML INJECTABLE / INJECTION AP RLD, RS 2011-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202515-002 MORPHINE SULFATE 4MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202515-003 MORPHINE SULFATE 8MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202515-004 MORPHINE SULFATE 10MG/ML INJECTABLE / INJECTION AP RLD 2011-11-14 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 144 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Morphine sulfate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MORPHINE SULFATE 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X3P646A2J0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1731537 Internal RxNorm lookup 1731545 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0409-2022-01 Morphine sulfate 1 in 1 CARTON INJECTION, SOLUTION 1 7 0409-2022-01 Morphine sulfate 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-2022 MORPHINE SULFATE INJECTION, SOLUTION MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 5 Current NDC, 2 package rows 20250425_ee8057d1-ed12-4e18-9efa-d83504abf612.zip
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0409-2022-01 00409202201 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-2022-01) / 50 mL in 1 VIAL, SINGLE-DOSE 2025-04-21 No No Current