Butalbital, Acetaminophen, and Caffeine

Product NDC: 16714-170
11-digit product format: 167140170
Labeler code: 16714
Product ID: 16714-170_c884344b-2520-4874-866c-bf9798b506d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, and Caffeine
Dosage form: CAPSULE
Route: ORAL
Labeler: NORTHSTAR RX LLC
Application: ANDA213046
Marketing category: ANDA
Marketing start: 2020-07-01
Substance: ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength: 300; 50; 40 mg/1; mg/1; mg/1
Pharmacologic classes: Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	16714-170		D	Discontinued by firm		2026-08-03
excluded package	package	16714-170	16714-170-01	D	Discontinued by firm		2026-08-03

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
A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA		2020-07-01

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A213046-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213046-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	300MG;50MG;40MG	CAPSULE / ORAL	AA	2020-07-01	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213046-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213046-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213046-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213046-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213046-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213046-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213046-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213046-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213046-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213046-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213046-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213046-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213046-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213046-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213046-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213046-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213046-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213046-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213046-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213046-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213046-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213046-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213046-001	AA	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213046-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213046-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213046-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213046-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213046-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213046-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213046-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213046-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213046-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213046-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213046-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213046-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213046-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213046-001	AA	1	`a50c72e98297…`

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
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
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
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-170-01	Butalbital, Acetaminophen, and Caffeine	100 in 1 BOTTLE	CAPSULE	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-170-01	EA - Each	16714-170	d160a0ac-aa9b-42e8-8f69-00bd738c8dbb	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-170	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULE [NORTHSTAR RX LLC]	1	Current NDC, Legacy NDC, 1 package rows	20201006_83a63e9b-0a97-4725-bcbb-906fb678ba42.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Butalbital, Acetaminophen and Caffeine	BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE	Sun Pharmaceutical Industries, Inc.	a68de112-f5af-49ba-a8a8-3adbaa7df36e	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213046 application number: ANDA213046

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
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
889520	butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG Oral Capsule	PSN	83a63e9b-0a97-4725-bcbb-906fb678ba42	1
889520	acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule	SCD	83a63e9b-0a97-4725-bcbb-906fb678ba42	1
889520	APAP 300 MG / butalbital 50 MG / caffeine 40 MG Oral Capsule	SY	83a63e9b-0a97-4725-bcbb-906fb678ba42	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-170-01	16714017001	100 CAPSULE in 1 BOTTLE (16714-170-01)	100 capsule	2020-09-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Butalbital, Acetaminophen and Caffeine Capsules, USP 50 mg, 300 mg and 40 mg	NORTHSTAR RX LLC	2020-10-01	HUMAN PRESCRIPTION DRUG LABEL	1