Acetaminophen, Caffeine, Dihydrocodeine Bitartrate

Product NDC: 42195-840
Requested package NDC: 42195-840-10
11-digit product format: 421950840
Labeler code: 42195
Product ID: 42195-840_8f97e457-8e1b-40fd-944c-f3806d9cc1d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
Dosage form: CAPSULE
Route: ORAL
Labeler: Xspire Pharma, Llc
Application: ANDA204785
Marketing category: ANDA
Marketing start: 2015-08-05
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
Active strength: 321 mg/1; mg/1; mg/1
Pharmacologic classes: Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2022-12-31
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	42195-840	42195-840-10	I	Inactivated by FDA		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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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

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
A204785-001	TREZIX	ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE	320.5MG;30MG;16MG	CAPSULE / ORAL			2014-11-26

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204785-001	TREZIX	320.5MG;30MG;16MG	CAPSULE / ORAL	2014-11-26	`f41ea6bd6efb…`

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
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42195-840-10	2024-01-30	C162847	48780-1	ba0f9c33-11f4-a910-e053-dadaa90a0b85	Acetaminophen, Caffeine and Dihydrocodeine Bitartrate CIII 320.5 mg / 30 mg / 16 mg Capsules Rx only
42195-840-10	2021-02-02	C162847	48780-1	ba0f9c33-11f4-a910-e053-dadaa90a0b85	Acetaminophen, Caffeine and Dihydrocodeine Bitartrate CIII 320.5 mg / 30 mg / 16 mg Capsules Rx only
42195-840-10	2021-01-29	C162847	48780-1	ba0f9c33-11f4-a910-e053-dadaa90a0b85	Acetaminophen, Caffeine and Dihydrocodeine Bitartrate CIII 320.5 mg / 30 mg / 16 mg Capsules Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42195-840-10	Acetaminophen, Caffeine, Dihydrocodeine Bitartrate	100 in 1 BOTTLE	CAPSULE	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42195-840-10	EA - Each	42195-840	320f1f6a-f210-4691-8395-b5ecd10adaa3	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1
CAFFEINE	ACTIVE INGREDIENT	3G6A5W338E	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1
DIHYDROCODEINE BITARTRATE	ACTIVE INGREDIENT	8LXS95BSA9	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1
CAFFEINE	ACTIVE MOIETY	3G6A5W338E	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1
DIHYDROCODEINE	ACTIVE MOIETY	N9I9HDB855	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1
CROSPOVIDONE (15 MPA.S AT 5%)	INACTIVE INGREDIENT	68401960MK	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42195-840	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA, LLC]	3	Legacy NDC, 1 package rows	20210203_76e033b0-01c1-42df-bb64-f8ca401cfb6b.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
Trezix	ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE	Proficient Rx LP	45c3c2a1-6a89-471e-b6d4-5a4cd73b987a	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204785 application number: ANDA204785

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE
8LXS95BSA9	DIHYDROCODEINE BITARTRATE	5965-13-9	DIHYDROCODEINE BITARTRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1596108	acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule	PSN	76e033b0-01c1-42df-bb64-f8ca401cfb6b	3
1596108	acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule	SCD	76e033b0-01c1-42df-bb64-f8ca401cfb6b	3
1596108	APAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule	SY	76e033b0-01c1-42df-bb64-f8ca401cfb6b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42195-840-10	42195084010	100 CAPSULE in 1 BOTTLE (42195-840-10)	100 capsule	2015-08-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen, Caffeine and Dihydrocodeine Bitartrate CIII 320.5 mg / 30 mg / 16 mg Capsules Rx only	Xspire Pharma, Llc	2021-01-30	HUMAN PRESCRIPTION DRUG LABEL	3