Home NDC 68047-722-01 butalbital and acetaminophen
Product NDC 68047-722
Requested package NDC 68047-722-01
11-digit product format 680470722
Labeler code 68047
Product ID 68047-722_cddc7e52-4eb8-7f7d-e053-2a95a90a2c5d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name butalbital and acetaminophen
Dosage form TABLET
Route ORAL
Labeler Larken Laboratories, Inc.
Application ANDA203484
Marketing category ANDA
Marketing start 2015-12-04
Marketing end 0000-00-00
Substance BUTALBITAL; ACETAMINOPHEN
Active strength 25 mg/1; mg/1
Pharmacologic classes Barbiturates [CS],Barbiturate [EPC]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203484-001 ALLZITAL ACETAMINOPHEN; BUTALBITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 A203484-002 BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL 325MG;50MG TABLET / ORAL AA 2015-12-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 3 · 86 observed 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 2026-09-14 22:38:34 2026-08 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL AA RS 2015-12-04 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL RS 2015-12-04 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL RS 2015-12-04 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL RS 2015-12-04 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68047-722-01 68047072201 100 TABLET in 1 BOTTLE (68047-722-01) 100 tablet 2015-12-04 0000-00-00 No No Current