Home NDC 76329-1912 Morphine Sulfate
Product NDC 76329-1912
11-digit product format 763291912
Labeler code 76329
Product ID 76329-1912_99799101-d92b-485b-93ec-f2b5a2e5ca26
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Morphine Sulfate
Dosage form INJECTION
Route INTRAVENOUS
Labeler International Medication Systems, Limited
Application ANDA202861
Marketing category ANDA
Marketing start 2022-01-20
Substance MORPHINE SULFATE
Active strength 1 mg/30mL
Pharmacologic classes Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 2026-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 76329-1912 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 76329-1912 76329-1912-1 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 A202861-001 MORPHINE SULFATE MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29
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.
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 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A202861-001 MORPHINE SULFATE 1MG/ML INJECTABLE / INJECTION 2021-04-29 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Morphine Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MORPHINE SULFATE 1 mg/30mL
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 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 76329-1912-0 Morphine Sulfate 30 mL in 1 VIAL INJECTION 30 8 76329-1912-1 Morphine Sulfate 10 in 1 PACKAGE INJECTION 10 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76329-1912 MORPHINE SULFATE (MORPHINE SULFATE ) INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED ] 8 Current NDC, Legacy NDC, 2 package rows 20250112_1034467f-d436-4b87-a902-c7e8885daa8a.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76329-1912-0 76329191200 30 mL in 1 VIAL 30 ml Historical 76329-1912-1 76329191201 10 VIAL in 1 PACKAGE (76329-1912-1) / 30 mL in 1 VIAL (76329-1912-0) 10 vial 2022-01-20 0000-00-00 No No Current