Home NDC 0409-3814 Morphine Sulfate
Product NDC 0409-3814
11-digit product format 004093814
Labeler code 0409
Product ID 0409-3814_0a2ba20b-448f-4412-9899-b82040ebfa7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form INJECTION, SOLUTION
Route EPIDURAL; INTRATHECAL; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA073509
Marketing category ANDA
Marketing start 2005-08-10
Substance MORPHINE SULFATE
Active strength .5 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A073509-001 MORPHINE SULFATE MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A073509-001 AP
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 · 42 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 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A073509-001 MORPHINE SULFATE 0.5MG/ML INJECTABLE / INJECTION AP 1992-09-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 .5 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 1728783 Internal RxNorm lookup 1728800 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 0409-3814-11 Morphine Sulfate 10 mL in 1 VIAL, GLASS INJECTION, SOLUTION 10 29 0409-3814-12 Morphine Sulfate 5 in 1 CARTON INJECTION, SOLUTION 5 29
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.] 11 MORPHINE ACTIVE MOIETY 76I7G6D29C MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-3814 MORPHINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 26 Current NDC, Legacy NDC, 2 package rows 20241208_1d181906-f3ec-4222-1883-e61577a3122e.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 · 1 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 0409-3814-11 00409381411 10 mL in 1 VIAL, GLASS 10 ml Historical 0409-3814-12 00409381412 5 VIAL, GLASS in 1 CARTON (0409-3814-12) / 10 mL in 1 VIAL, GLASS (0409-3814-11) 2005-08-10 0000-00-00 No No Current