Orphengesic Forte

Product NDC: 61825-999
11-digit product format: 618250999
Labeler code: 61825
Product ID: 61825-999_9bbb5fc9-decc-4cec-e053-2a95a90ac30d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Orphenadrine Citrate, Aspirin and Caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Galt Pharmaceuticals, LLC
Application: ANDA075141
Marketing category: ANDA
Marketing start: 2019-06-17
Marketing end: 0000-00-00
Substance: ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE
Active strength: 50 mg/1; mg/1; mg/1
Pharmacologic classes: Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61825-999		D	Discontinued by firm		2026-08-03
excluded package	package	61825-999	61825-999-60	D	Discontinued by firm		2026-08-03

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	61825-999-60	`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	61825-999-60	`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	61825-999-60	`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	61825-999-60	`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	61825-999-60	`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	61825-999-60	`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	61825-999-60	`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	61825-999-60	`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	61825-999-60	`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	61825-999-60	`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	61825-999-60	`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	61825-999-60	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075141-001	ORPHENGESIC	ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	385MG;30MG;25MG	TABLET / ORAL			1998-05-29
A075141-002	ORPHENGESIC FORTE	ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29

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 · 82 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	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL	AB		1998-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075141-001	ORPHENGESIC	385MG;30MG;25MG	TABLET / ORAL			1998-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075141-002	ORPHENGESIC FORTE	770MG;60MG;50MG	TABLET / ORAL		RS	1998-05-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075141-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075141-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075141-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075141-002	AB	1	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61825-999-60	EA - Each	61825-999	72982bfc-724f-488c-8952-8f0fbf14ca99	1	2019-08-06

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Norgesic	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE	Galt Pharmaceuticals, LLC	be2761bc-e537-4039-846a-2ffa3d8b2afc	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075141 application number: ANDA075141
Norgesic Forte	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE	Poly Pharmaceuticals, Inc.	85a3b808-b476-f2f0-e053-2a91aa0af21f	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075141 application number: ANDA075141
Orphenadrine Citrate, Aspirin and Caffeine	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE	Atland Pharmaceuticals, LLC	7776aae6-3cbd-4aed-9aac-4bed80339e27	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075141 application number: ANDA075141
ORPHENGESIC FORTE	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE	Galt Pharmaceuticals, LLC	5bc485db-9d96-4291-aaa3-2a96ebf3098a	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075141 application number: ANDA075141
Orphenadrine Citrate, Aspirin and Caffeine	ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE	Atland Pharmaceuticals, LLC	61ca2af1-081c-411c-90ce-ec6d9e3157b2	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075141 application number: ANDA075141

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X0A40N8I4S	ORPHENADRINE CITRATE	4682-36-4	ORPHENADRINE CITRATE
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ORPHENGESIC ® FORTE TABLETS (Orphenadrine Citrate, Aspirin and Caffeine tablets 50mg/ 770mg/ 60mg USP)	Galt Pharmaceuticals, LLC	2020-01-09	HUMAN PRESCRIPTION DRUG LABEL	2