Morphine sulfate
- Product NDC
- 0228-3116
- 11-digit product format
- 002283116
- Labeler code
- 0228
- Product ID
- 0228-3116_d41b3be8-7ef7-4b1d-9692-fffd13baf96d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine sulfate
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA079040
- Marketing category
- ANDA
- Marketing start
- 2014-02-04
- Substance
- MORPHINE SULFATE
- Active strength
- 45 mg/1
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079040-001 | MORPHINE SULFATE | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | ||
| A079040-002 | MORPHINE SULFATE | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | ||
| A079040-003 | MORPHINE SULFATE | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | ||
| A079040-004 | MORPHINE SULFATE | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | ||
| A079040-005 | MORPHINE SULFATE | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | ||
| A079040-006 | MORPHINE SULFATE | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079040-005 | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A079040-006 | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079040-005 | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A079040-006 | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079040-005 | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079040-006 | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079040-005 | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A079040-006 | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079040-005 | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079040-006 | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079040-005 | MORPHINE SULFATE | 90MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079040-006 | MORPHINE SULFATE | 120MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 2013-01-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079040-001 | MORPHINE SULFATE | 30MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079040-002 | MORPHINE SULFATE | 45MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079040-003 | MORPHINE SULFATE | 60MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079040-004 | MORPHINE SULFATE | 75MG | CAPSULE, EXTENDED RELEASE / ORAL | 2013-01-16 | 03ed91905a0d… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Morphine sulfate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MORPHINE SULFATE | 45 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| X3P646A2J0 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 89941d4c-522d-cee0-b273-43cfa7ef6d35 | Product name | 4 | 20250516 |
| f15f9e76-db42-8a50-218a-5ef5affa58da | Product name | 4 | 20240216 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 944b0689-73f4-6a2f-c654-1180896353c0 | Product name | 4 | 20220210 |
| 67e166c6-23d4-4709-b77d-5ca6182dcae0 | Product name | 1 | 20180830 |
| c573a64c-fe17-2eac-fbcb-788868b4ff6b | Product name | 9 | 20180619 |
| 7c1819cf-69a0-41dc-aeaa-a820729bc959 | Product name | 1 | 20170406 |
| 7a68fc31-10e5-df04-67e0-3a613a2d4d2e | Product name | 5 | 20161114 |
| 175682a8-c657-45a2-9dfb-c565306b03c8 | Product name | 1 | 20160112 |
| b73dadd0-1b4a-4f88-956f-a2be216c8fad | Product name | 1 | 20151123 |
| 4c272b1c-87fc-ebc0-994d-ac28b1e0416e | Product name | 1 | 20140508 |
| 7a537f54-d322-5e54-a3a2-035d3e21c3c6 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0228-3116-11 | Morphine sulfate | 100 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 100 | 47 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | Actavis Pharma, Inc. | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 2026-03-01 | Boxed warning, Warnings, Adverse reactions | 079040 ANDA079040 0228-3116 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 892297 | morphine sulfate 120 MG 24HR Extended Release Oral Capsule | PSN | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892342 | morphine sulfate 30 MG 24HR Extended Release Oral Capsule | PSN | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 894942 | morphine sulfate 45 MG 24HR Extended Release Oral Capsule | PSN | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892349 | morphine sulfate 60 MG 24HR Extended Release Oral Capsule | PSN | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 894970 | morphine sulfate 75 MG 24HR Extended Release Oral Capsule | PSN | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892355 | morphine sulfate 90 MG 24HR Extended Release Oral Capsule | PSN | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892297 | 24 HR morphine sulfate 120 MG Extended Release Oral Capsule | SCD | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892342 | 24 HR morphine sulfate 30 MG Extended Release Oral Capsule | SCD | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 894942 | 24 HR morphine sulfate 45 MG Extended Release Oral Capsule | SCD | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892349 | 24 HR morphine sulfate 60 MG Extended Release Oral Capsule | SCD | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 894970 | 24 HR morphine sulfate 75 MG Extended Release Oral Capsule | SCD | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892355 | 24 HR morphine sulfate 90 MG Extended Release Oral Capsule | SCD | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892297 | 24 HR MS 120 MG Extended Release Oral Capsule | SY | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892342 | 24 HR MS 30 MG Extended Release Oral Capsule | SY | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 894942 | 24 HR MS 45 MG Extended Release Oral Capsule | SY | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892349 | 24 HR MS 60 MG Extended Release Oral Capsule | SY | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 894970 | 24 HR MS 75 MG Extended Release Oral Capsule | SY | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892355 | 24 HR MS 90 MG Extended Release Oral Capsule | SY | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892297 | morphine sulfate 120 MG 24 HR Extended Release Oral Capsule | SY | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892342 | morphine sulfate 30 MG 24 HR Extended Release Oral Capsule | SY | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 894942 | morphine sulfate 45 MG 24 HR Extended Release Oral Capsule | SY | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892349 | morphine sulfate 60 MG 24 HR Extended Release Oral Capsule | SY | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 894970 | morphine sulfate 75 MG 24 HR Extended Release Oral Capsule | SY | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
| 892355 | morphine sulfate 90 MG 24 HR Extended Release Oral Capsule | SY | 2da87bfa-11fd-43e3-8fef-d16ebeb15680 | 47 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0228-3116-11 | 00228311611 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0228-3116-11) | 2014-02-04 | 0000-00-00 | No | No | Current |