Vtol LQ

Product NDC: 70154-111
Requested package NDC: 70154-111-16
11-digit product format: 701540111
Labeler code: 70154
Product ID: 70154-111_ed1e4388-d290-ff7d-e053-2a95a90a61ca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital, acetaminophen and caffeine
Dosage form: SYRUP
Route: ORAL
Labeler: Monarch PCM, LLC
Application: ANDA040387
Marketing category: ANDA
Marketing start: 2019-11-11
Marketing end: 2023-11-10
Substance: ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength: 325 mg/15mL; mg/15mL; mg/15mL
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: 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70154-111	70154-111-16	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL		RS	2003-01-31

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040387-001	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	325MG/15ML;50MG/15ML;40MG/15ML	SOLUTION / ORAL	RS	2003-01-31	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70154-111-16	ML - Milliliter	70154-111	291d20e7-101e-4f8e-a5e0-96bdc7ebf414	1	2020-03-10

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	Genus Lifesciences Inc.	5f603b0d-69e5-4c02-b6b3-b4705e243e9a	2025-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040387 application number: ANDA040387

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70154-111-16	70154011116	473 mL in 1 BOTTLE, PLASTIC (70154-111-16)	473 ml	2019-11-11	2023-11-10	No	No	Current