FDA.reportPublic FDA data

Topcare Ibuprofen

Product NDC
36800-303
11-digit product format
368000303
Labeler code
36800
Product ID
36800-303_eed2a9b4-dbd2-42c8-8d81-0a2b03e3100e
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA206581
Marketing category
ANDA
Marketing start
2016-03-23
Marketing end
0000-00-00
Substance
IBUPROFEN SODIUM
Active strength
256 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36800-303DDiscontinued by firm2026-07-31
excluded packagepackage36800-30336800-303-60DDiscontinued 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
A206581-001IBUPROFEN SODIUMIBUPROFEN SODIUMEQ 200MG BASETABLET / ORAL2015-08-03

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 22:54:322026-06A206581-001IBUPROFEN SODIUMEQ 200MG BASETABLET / ORAL2015-08-03a50c72e98297…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-303-60368000303601 BOTTLE in 1 CARTON (36800-303-60) > 20 TABLET, FILM COATED in 1 BOTTLE1 bottle2016-03-230000-00-00NoNoCurrent