Home NDC 79739-7192 Butalbital, Aspirin, and Caffeine
Product NDC 79739-7192
11-digit product format 797397192
Labeler code 79739
Product ID 79739-7192_1383f9e3-02c6-4363-920c-8e24e51f22e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, Aspirin, and Caffeine
Dosage form CAPSULE
Route ORAL
Labeler LGM PHARMA SOLUTIONS, LLC
Application ANDA205230
Marketing category ANDA
Marketing start 2021-10-18
Substance ASPIRIN; BUTALBITAL; CAFFEINE
Active strength 500; 50; 40 mg/1; mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 9 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 2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 79739-7192-5 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 79739-7192-1 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 79739-7192-5 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 79739-7192-1 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 79739-7192-5 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 79739-7192-1 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE ASPIRIN; BUTALBITAL; CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18
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 2026-08-18 06:07:40 2026-07 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205230-001 BUTALBITAL, ASPIRIN AND CAFFEINE 500MG;50MG;40MG CAPSULE / ORAL 2021-10-18 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Butalbital, Aspirin, and Caffeine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUTALBITAL 50 mg/1 ASPIRIN 500 mg/1 CAFFEINE 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination KHS0AZ4JVK Internal UNII lookup R16CO5Y76E Internal UNII lookup 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2583731 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 79739-7192-1 2024-06-21 BAspC 7192 - Butalbital, Aspirin, and Caffeine Capsules 79739-7192-5 2024-06-21 BAspC 7192 - Butalbital, Aspirin, and Caffeine Capsules 79739-7192-1 2024-01-30 BAspC 7192 - Butalbital, Aspirin, and Caffeine Capsules 79739-7192-5 2024-01-30 BAspC 7192 - Butalbital, Aspirin, and Caffeine Capsules
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 79739-7192-1 Butalbital, Aspirin, and Caffeine 100 in 1 BOTTLE CAPSULE 100 2 79739-7192-5 Butalbital, Aspirin, and Caffeine 500 in 1 BOTTLE CAPSULE 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79739-7192 BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LGM PHARMA SOLUTIONS, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20240622_a1c7b964-af71-4427-8f13-73b5e69ca525.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 79739-7192-1 79739719201 100 CAPSULE in 1 BOTTLE (79739-7192-1) 100 capsule 2021-10-18 0000-00-00 No No Current 79739-7192-5 79739719205 500 CAPSULE in 1 BOTTLE (79739-7192-5) 500 capsule 2021-10-18 0000-00-00 No No Current