Orphenadrine Citrate, Aspirin and Caffeine

Product NDC: 74157-999
Requested package NDC: 74157-999-60
11-digit product format: 741570999
Labeler code: 74157
Product ID: 74157-999_d2aca771-3b03-41a1-e053-2995a90acb50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: orphenadrine citrate, aspirin and caffeine
Dosage form: TABLET
Route: ORAL
Labeler: INA Pharmaceutics, Inc
Application: ANDA075141
Marketing category: ANDA
Marketing start: 2020-05-27
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: 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	74157-999	74157-999-60	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 · 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 · 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
74157-999-60	EA - Each	74157-999	7b34fb4b-64e8-413a-b38b-a0f458f3b1e3	1	2020-07-13

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
74157-999-60	74157099960	60 TABLET in 1 BOTTLE, PLASTIC (74157-999-60)	60 tablet	2020-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Orphenadrine Citrate, Aspirin and Caffeine tablets 50 mg/ 770 mg/ 60 mg USP	INA Pharmaceutics, Inc	2021-12-08	HUMAN PRESCRIPTION DRUG LABEL	3