Home NDC 0781-2270 Butalbital, aspirin, and caffeine
Product NDC 0781-2270
11-digit product format 007812270
Labeler code 0781
Product ID 0781-2270_e179c768-32ba-49b7-b59a-55b2cfa54619
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, aspirin, and caffeine
Dosage form CAPSULE
Route ORAL
Labeler Sandoz Inc
Application ANDA086996
Marketing category ANDA
Marketing start 2024-09-03
Substance ASPIRIN; BUTALBITAL; CAFFEINE
Active strength 325; 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 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 A086996-002 LANORINAL ASPIRIN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A086996-002 AA
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 · 41 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 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA 1985-10-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA 1985-10-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA 1985-10-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA 1985-10-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA 1985-10-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA 1985-10-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA 1985-10-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA 1985-10-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA 1985-10-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA 1985-10-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA 1985-10-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA 1985-10-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A086996-002 LANORINAL 325MG;50MG;40MG CAPSULE / ORAL AA RS 1985-10-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 325 mg/1 ASPIRIN 50 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 238134 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 0781-2270-01 Butalbital, aspirin, and caffeine 100 in 1 BOTTLE CAPSULE 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-2270 BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [SANDOZ INC] 2 Current NDC, 1 package rows 20241206_0e5e3842-fc6c-4a24-8e5c-522701f7c291.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join butalbital, aspirin, and caffeine BUTALBITAL, ASPIRIN, AND CAFFEINE Chartwell RX, LLC e69d8bb1-ba09-42e2-8372-7f5e0a906174 2025-12-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 086996 application number: ANDA086996 Butalbital, aspirin, and caffeine BUTALBITAL, ASPIRIN, AND CAFFEINE Sandoz Inc 0e5e3842-fc6c-4a24-8e5c-522701f7c291 2024-12-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 086996 application number: ANDA086996 ndc (product): 0781-2270 Butalbital, aspirin, and caffeine BUTALBITAL, ASPIRIN, AND CAFFEINE Lannett Company, Inc. ba60b130-33cd-4db9-92a7-2cab8ded0737 2021-05-24 Warnings, Adverse reactions Exact identifier application applno (ANDA): 086996 application number: ANDA086996
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0781-2270-01 00781227001 100 CAPSULE in 1 BOTTLE (0781-2270-01) 100 capsule 2024-09-03 No No Current