Home NDC 0527-1552 Butalbital, aspirin, and caffeine
Product NDC 0527-1552
11-digit product format 005271552
Labeler code 0527
Product ID 0527-1552_6b42bae1-bbc0-4337-8836-592b1beb7330
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Butalbital, aspirin, and caffeine
Dosage form CAPSULE
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA086996
Marketing category ANDA
Marketing start 1985-10-11
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 0527-1552-01 Butalbital, aspirin, and caffeine 100 in 1 BOTTLE CAPSULE 100 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ASPIRIN ACTIVE INGREDIENT R16CO5Y76E BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 BUTALBITAL ACTIVE INGREDIENT KHS0AZ4JVK BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 ASPIRIN ACTIVE MOIETY R16CO5Y76E BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 BUTALBITAL ACTIVE MOIETY KHS0AZ4JVK BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 CAFFEINE ACTIVE MOIETY 3G6A5W338E BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 ALCOHOL INACTIVE INGREDIENT 3K9958V90M BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 GELATIN INACTIVE INGREDIENT 2G86QN327L BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 SHELLAC INACTIVE INGREDIENT 46N107B71O BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7 TRIMYRISTIN INACTIVE INGREDIENT 18L31PSR28 BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0527-1552 BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [LANNETT COMPANY, INC.] 17 Current NDC, Legacy NDC, 1 package rows 20240131_ba60b130-33cd-4db9-92a7-2cab8ded0737.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 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 ndc (product): 0527-1552
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 0527-1552-01 00527155201 100 CAPSULE in 1 BOTTLE (0527-1552-01) 100 capsule 1985-10-11 0000-00-00 No No Current