FDA.reportPublic FDA data

Morphine Sulfate

Product NDC
42858-811
Requested package NDC
42858-811-17
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. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42858-81142858-811-17DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206420-001MORPHINE SULFATEMORPHINE SULFATE20MG/5MLSOLUTION / ORAL2016-07-12

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206420-001MORPHINE SULFATE20MG/5MLSOLUTION / ORAL2016-07-12a50c72e98297…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42858-811-1742858081117500 mL in 1 BOTTLE, PLASTIC (42858-811-17) 500 ml2016-07-120000-00-00NoNoCurrent