FDA.reportPublic FDA data

Phrenilin Forte

Product NDC
66992-955
11-digit product format
669920955
Labeler code
66992
Product ID
66992-955_109b9af7-e798-46d3-997c-5df01c73212b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, Caffeine
Dosage form
CAPSULE
Route
ORAL
Labeler
Wraser LLC
Application
ANDA206615
Marketing category
ANDA
Marketing start
2017-09-18
Marketing end
0000-00-00
Substance
BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active strength
50 mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Barbiturates [CS],Barbiturate [EPC]
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 productproduct66992-955DDiscontinued by firm2026-07-31
excluded packagepackage66992-95566992-955-10DDiscontinued 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
A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-04

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 22:54:322026-06A206615-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE300MG;50MG;40MGCAPSULE / ORAL2017-08-04a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66992-955-10EA - Each66992-95539b32db6-1149-4662-b7c2-99fdb004cd4112017-11-06