Home NDC 52544-956 Fiorinal with Codeine
Product NDC 52544-956
11-digit product format 525440956
Labeler code 52544
Product ID 52544-956_a08cf4c7-a32d-4941-b44e-f524d909944b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Aspirin, Caffeine, and Codeine Phosphate
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA019429
Marketing category NDA
Marketing start 1990-10-26
Marketing end 2020-03-31
Substance CODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ASPIRIN
Active strength 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
DEA schedule CIII
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52544-956-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52544-956-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52544-956-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52544-956-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52544-956-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52544-956-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52544-956-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52544-956-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52544-956-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52544-956-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52544-956-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 52544-956-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N019429-003 FIORINAL W/CODEINE ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1990-10-26
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 2 · 43 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 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1990-10-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1990-10-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 1990-10-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL AB RLD, RS 1990-10-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019429-003 FIORINAL W/CODEINE 325MG;50MG;40MG;30MG CAPSULE / ORAL RLD 1990-10-26 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ASPIRIN ACTIVE INGREDIENT R16CO5Y76E FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 CODEINE PHOSPHATE ACTIVE INGREDIENT GSL05Y1MN6 FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 ASPIRIN ACTIVE MOIETY R16CO5Y76E FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 CAFFEINE ACTIVE MOIETY 3G6A5W338E FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 CODEINE ANHYDROUS ACTIVE MOIETY UX6OWY2V7J FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 FD&C RED NO. 3 INACTIVE INGREDIENT PN2ZH5LOQY FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 GELATIN INACTIVE INGREDIENT 2G86QN327L FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FIORINAL WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE) CAPSULE [ACTAVIS PHARMA, INC.] 10