Morphine Sulfate
- Product NDC
- 42858-811
- 11-digit product format
- 428580811
- Labeler code
- 42858
- Product ID
- 42858-811_ce2b7c6b-57bb-452e-8ce0-2a2e76a91599
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Morphine Sulfate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Rhodes Pharmaceuticals L.P.
- Application
- ANDA206420
- Marketing category
- ANDA
- Marketing start
- 2016-07-12
- Marketing end
- 0000-00-00
- Substance
- MORPHINE SULFATE
- Active strength
- 20 mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 42858-811 | | D | Discontinued by firm | | 2026-07-31 |
| excluded package | package | 42858-811 | 42858-811-17 | D | Discontinued by firm | | 2026-07-31 |
Orange Book products#
Application-product, Trade name, Ingredient table| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|
| A206420-001 | MORPHINE SULFATE | MORPHINE SULFATE | 20MG/5ML | SOLUTION / ORAL | | | 2016-07-12 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42858-811-17 | 42858081117 | 500 mL in 1 BOTTLE, PLASTIC (42858-811-17) | 500 ml | 2016-07-12 | 0000-00-00 | No | No | Current |