Home NDC 68047-752-01 ALLZITAL
Product NDC 68047-752
Requested package NDC 68047-752-01
11-digit product format 680470752
Labeler code 68047
Product ID 68047-752_41348343-4fef-7234-e063-6394a90af41d
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
Substance ACETAMINOPHEN; BUTALBITAL
Active strength 325; 25 mg/1; mg/1
Pharmacologic classes Barbiturate [EPC], Barbiturates [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 2026-02-19 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…2022-03-09 01:35 UTC 2022-03 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL RS 2015-12-04 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203484-001 ALLZITAL 325MG;25MG TABLET / ORAL RS 2015-12-04 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203484-002 BUTALBITAL AND ACETAMINOPHEN 325MG;50MG TABLET / ORAL AA 2015-12-04 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ALLZITAL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUTALBITAL 325 mg/1 ACETAMINOPHEN 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KHS0AZ4JVK Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197426 Internal RxNorm lookup 1724446 Internal RxNorm lookup 2279007 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68047-752-01 ALLZITAL 100 in 1 BOTTLE TABLET 100 17 68047-752-30 ALLZITAL 30 in 1 BOTTLE TABLET 30 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68047-752 BUTALBITAL AND ACETAMINOPHEN TABLET BUTALBITAL AND ACETAMINOPHEN TABLET ALLZITAL (BUTALBITAL AND ACETAMINOPHEN) TABLET [LARKEN LABORATORIES, INC.] 16 Current NDC, Legacy NDC, 2 package rows 20241012_326c83fc-afed-45ad-9c87-f47968fa1d2a.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68047-752-01 68047075201 100 TABLET in 1 BOTTLE (68047-752-01) 100 tablet 2015-12-04 0000-00-00 No No Current