Home NDC 71205-962-90 Butalbital, Acetaminophen and Caffeine
Product NDC 71205-962
Requested package NDC 71205-962-90
11-digit product format 712050962
Labeler code 71205
Product ID 71205-962_52089539-a130-4592-8449-b5c792020a2c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Acetaminophen and Caffeine
Dosage form CAPSULE
Route ORAL
Labeler Proficient Rx LP
Application ANDA206615
Marketing category ANDA
Marketing start 2017-08-04
Marketing end 0000-00-00
Substance ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength 300 mg/1; mg/1; mg/1
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206615-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300MG;50MG;40MG CAPSULE / ORAL 2017-08-04
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A206615-001 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE 300MG;50MG;40MG CAPSULE / ORAL 2017-08-04 a50c72e98297…
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-962 BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE [PROFICIENT RX LP] 2 Legacy NDC 20220616_20d1047c-7c19-4c24-b6e8-8e688e47a29e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71205-962-90 71205096290 90 CAPSULE in 1 BOTTLE (71205-962-90) 90 capsule 2020-12-11 0000-00-00 No No Current