Butalbital, Aspirin, and Caffeine

Product NDC: 0591-3219
11-digit product format: 005913219
Labeler code: 0591
Product ID: 0591-3219_7405aa53-b345-4fbf-9c41-8a7a27cc90ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital, aspirin, and caffeine
Dosage form: CAPSULE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: NDA017534
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2003-10-06
Marketing end: 2023-05-31
Substance: ASPIRIN; BUTALBITAL; CAFFEINE
Active strength: 325 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: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0591-3219		D	Discontinued by firm		2026-10-05
excluded package	package	0591-3219	0591-3219-01	D	Discontinued by firm		2026-10-05

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	0591-3219-01	`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	0591-3219-01	`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	0591-3219-01	`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	0591-3219-01	`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	0591-3219-01	`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	0591-3219-01	`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	0591-3219-01	`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	0591-3219-01	`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	0591-3219-01	`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	0591-3219-01	`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	0591-3219-01	`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	0591-3219-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N017534-003	FIORINAL	ASPIRIN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16
N017534-005	FIORINAL	ASPIRIN; BUTALBITAL; CAFFEINE	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16

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 · 86 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	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017534-005	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1986-04-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1986-04-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017534-005	FIORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RLD	1986-04-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017534-003	FIORINAL	325MG;50MG;40MG	TABLET / ORAL		RLD	1986-04-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017534-005	FIORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RLD, RS	1986-04-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017534-003	FIORINAL	325MG;50MG;40MG	TABLET / ORAL		RLD	1986-04-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017534-005	FIORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RLD, RS	1986-04-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017534-003	FIORINAL	325MG;50MG;40MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	1986-04-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017534-005	FIORINAL	325MG;50MG;40MG	CAPSULE / ORAL	AA	RLD, RS	1986-04-16	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017534-005	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017534-005	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017534-005	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017534-005	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017534-005	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017534-005	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017534-005	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017534-005	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017534-005	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017534-005	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017534-005	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017534-005	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017534-005	AA	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3219-01	EA - Each	0591-3219	80a38469-6f5a-4488-af6c-1ab68b4f5f74	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [ACTAVIS PHARMA, INC.]	5
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1
aspirin	ACTIVE INGREDIENT	R16CO5Y76E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1
butalbital	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
BUTALBITAL	ACTIVE INGREDIENT	KHS0AZ4JVK	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
caffeine	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1
aspirin	ACTIVE MOIETY	R16CO5Y76E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1
butalbital	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
BUTALBITAL	ACTIVE MOIETY	KHS0AZ4JVK	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
caffeine	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE [STAT RX USA LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
KHS0AZ4JVK	BUTALBITAL	77-26-9	BUTALBITAL
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238134	butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule	PSN	166e131d-9c1a-461f-bf33-e45d4ec36ff2	1
238134	butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule	PSN	aa9bfa49-c3b3-419d-a283-5ea0fd6fc3a0	1
238134	butalbital 50 MG / aspirin 325 MG / caffeine 40 MG Oral Capsule	PSN	c69954d9-9b30-484f-8e4a-5b1fc7dd197d	1
238134	aspirin 325 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule	SCD	166e131d-9c1a-461f-bf33-e45d4ec36ff2	1
238134	aspirin 325 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule	SCD	aa9bfa49-c3b3-419d-a283-5ea0fd6fc3a0	1
238134	aspirin 325 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule	SCD	c69954d9-9b30-484f-8e4a-5b1fc7dd197d	1
238134	ASA 325 MG / butalbital 50 MG / Caffeine 40 MG Oral Capsule	SY	166e131d-9c1a-461f-bf33-e45d4ec36ff2	1
238134	ASA 325 MG / butalbital 50 MG / Caffeine 40 MG Oral Capsule	SY	aa9bfa49-c3b3-419d-a283-5ea0fd6fc3a0	1
238134	ASA 325 MG / butalbital 50 MG / Caffeine 40 MG Oral Capsule	SY	c69954d9-9b30-484f-8e4a-5b1fc7dd197d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3219-01	00591321901	100 CAPSULE in 1 BOTTLE (0591-3219-01)	100 capsule	2003-10-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Butalbital, Aspirin, and Caffeine Capsules, USP C-III Content Updated : April 2021 Rx only	Actavis Pharma, Inc.	2021-04-01	HUMAN PRESCRIPTION DRUG LABEL	11
Butalbital, Aspirin, and Caffeine Capsules, USP C-III Revised: June 2009 Rx only 1901100609	Aidarex Pharmaceuticals LLC	2013-12-23	HUMAN PRESCRIPTION DRUG LABEL	1
Butalbital, Aspirin, and Caffeine Capsules, USP C-III Revised: June 2009 Rx only 1901100609	STAT RX USA LLC	2010-09-22	HUMAN PRESCRIPTION DRUG LABEL	1
Butalbital, Aspirin, and Caffeine Capsules	Rebel Distributors Corp	2010-09-20	HUMAN PRESCRIPTION DRUG LABEL	1