Application 019999
- Type
- NDA
- Sponsor
- MERIDIAN MEDCL TECHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MORPHINE SULFATE | MORPHINE SULFATE | INJECTABLE;INJECTION | 15MG/ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | MORPHINE SULFATE | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 |
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 | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019999-001 | MORPHINE SULFATE | 15MG/ML | INJECTABLE / INJECTION | RLD, RS | 1990-07-12 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019999-001 | MORPHINE SULFATE | 15MG/ML | INJECTABLE / INJECTION | RLD, RS | 1990-07-12 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019999-001 | MORPHINE SULFATE | 15MG/ML | INJECTABLE / INJECTION | RLD, RS | 1990-07-12 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019999-001 | MORPHINE SULFATE | 15MG/ML | INJECTABLE / INJECTION | RLD, RS | 1990-07-12 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019999-001 | MORPHINE SULFATE (AUTOINJECTOR) | 10MG/0.7ML (10MG/0.7ML) | SOLUTION / INTRAMUSCULAR | RLD | 1990-07-12 | cb3db0bc1861… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Morphine Sulfate | MORPHINE SULFATE | Redpharm Drug | 58476a6b-b54b-5491-e063-6394a90a38c6 | 2026-08-05 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | SpecGx LLC | 8b69f67f-30b3-4982-953e-5a4b87ec6ac6 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| MORPHINE SULFATE | MORPHINE SULFATE | St. Mary's Medical Park Pharmacy | 57ee014e-744e-65e1-e063-6394a90a8c93 | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | SpecGx LLC | 242c2512-1d49-486b-a9c3-6905f667799e | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 595243fe-a4b1-479a-99d6-a084a4181891 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | Morphine sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Hikma Pharmaceuticals USA Inc. | 6023606c-150c-40c5-9175-598efe2a56c3 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | 6654b91e-3b3f-4062-ac65-a2a70f942da4 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | bb6b3439-9f0c-45f5-bf6f-c7a971af0a8f | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | 76966c05-df75-4072-ae99-97e42f91ab75 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose, Inc. | 67f0ee8d-696e-4c08-9007-3df0e3988bad | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate Extended Release | MORPHINE SULFATE | Major Pharmaceuticals | dbb37dfd-0196-45f7-b9ca-393f56cf1d28 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Bryant Ranch Prepack | 367d508b-3226-42a9-8dc6-f67cdc9979f3 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Precision Dose Inc. | 8d800d8e-8fe2-453b-a8ac-dcf7c47e55fc | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| MS Contin | MORPHINE SULFATE | Rhodes Pharmaceuticals LLC | c354b3bf-86c0-4bb8-8b1f-be2164942698 | 2026-05-18 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate Extended Release | MORPHINE SULFATE | Rhodes Pharmaceuticals LLC | 19c7d9cc-6ce2-4c5c-8c3f-c24fd3342804 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate | MORPHINE SULFATE | Hospira, Inc. | 1d181906-f3ec-4222-1883-e61577a3122e | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | Morphine Sulfate MORPHINE SULFATE |
| Morphine Sulfate Extended Release | MORPHINE SULFATE | Bryant Ranch Prepack | 2dd52157-3121-41ed-abc2-99b269531e56 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| MORPHINE SULFATE | MORPHINE SULFATE | Bryant Ranch Prepack | d1b0b4ac-69d9-44bf-b7a3-229bd89b9fd6 | 2026-04-13 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE MORPHINE SULFATE |
| Morphine Sulfate Extended Release | MORPHINE SULFATE | Bryant Ranch Prepack | c94d9da6-7a12-44ee-a38f-3323ee27842c | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |
| Morphine Sulfate ER | MORPHINE SULFATE | Bryant Ranch Prepack | 872ceecb-1f14-7a43-7451-e4650a01fbd9 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | MORPHINE SULFATE |