Home NDC 0409-1890 Morphine Sulfate
Product NDC 0409-1890
11-digit product format 004091890
Labeler code 0409
Product ID 0409-1890_56671cfe-7548-442e-a2b5-ffebebf65ade
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MORPHINE SULFATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA202515
Marketing category NDA
Marketing start 2012-08-23
Substance MORPHINE SULFATE
Active strength 2 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 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MORPHINE SULFATE MORPHINE SULFATE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2011-11-14 N202515-006 MORPHINE SULFATE MORPHINE SULFATE 50MG/ML INJECTABLE / INJECTION RLD,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 2 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 894912 Internal RxNorm lookup 998212 Internal RxNorm lookup 998213 Internal RxNorm lookup 1729197 Internal RxNorm lookup 1731995 Internal RxNorm lookup 1732014 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 0409-1890-01 Morphine Sulfate 10 in 1 CARTON INJECTION, SOLUTION 10 26 0409-1890-03 Morphine Sulfate 1 mL in 1 CARTRIDGE INJECTION, SOLUTION 1 26 0409-1890-13 Morphine Sulfate 1 mL in 1 SYRINGE INJECTION, SOLUTION 1 26 0409-1890-23 Morphine Sulfate 10 in 1 CELLO PACK INJECTION, SOLUTION 10 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MORPHINE SULFATE ACTIVE INGREDIENT X3P646A2J0 MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 4 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 4 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 4 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 4 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 4 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1890 MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 23 Current NDC, Legacy NDC, 4 package rows 20240103_be420e8b-bcb0-49b5-bb4d-1df8b9959809.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 Units Marketing start Marketing end Sample Exclude flag Status 0409-1890-01 00409189001 10 CARTRIDGE in 1 CARTON (0409-1890-01) / 1 mL in 1 CARTRIDGE (0409-1890-03) 10 cartridge 2012-08-23 0000-00-00 No No Current 0409-1890-03 00409189003 1 mL in 1 CARTRIDGE 1 ml Historical 0409-1890-13 00409189013 1 mL in 1 SYRINGE 1 ml Historical 0409-1890-23 00409189023 10 SYRINGE in 1 CELLO PACK (0409-1890-23) / 1 mL in 1 SYRINGE (0409-1890-13) 10 syringe 2021-01-11 0000-00-00 No No Current