Norgesic

Product NDC: 61825-305
11-digit product format: 618250305
Labeler code: 61825
Product ID: 61825-305_47da9e12-c9c2-d80e-e063-6294a90a86aa
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: 2022-05-16
Substance: ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
Active strength: 385; 30; 25 mg/1; mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Centrally-mediated Muscle Relaxation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Muscle Relaxant [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Norgesic
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ORPHENADRINE CITRATE	385 mg/1
ASPIRIN	30 mg/1
CAFFEINE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X0A40N8I4S	Internal UNII lookup
R16CO5Y76E	Internal UNII lookup
3G6A5W338E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
994528	Internal RxNorm lookup
994530	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
be2761bc-e537-4039-846a-2ffa3d8b2afc	Available on FDA.report

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
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
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
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
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
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	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
61825-305-60	Norgesic	60 in 1 BOTTLE, PLASTIC	TABLET	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61825-305-60	EA - Each	61825-305	5e645760-c65c-4cf9-a2cb-906ee981e0e0	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61825-305	NORGESIC (ORPHENADRINE CITRATE, ASPIRIN AND CAFFEINE) TABLET [GALT PHARMACEUTICALS, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20240110_be2761bc-e537-4039-846a-2ffa3d8b2afc.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 · 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 ndc (product): 61825-305
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
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE
X0A40N8I4S	ORPHENADRINE CITRATE	4682-36-4	ORPHENADRINE CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
994530	Norgesic 25 MG / 385 MG / 30 MG Oral Tablet	PSN	be2761bc-e537-4039-846a-2ffa3d8b2afc	3
994528	orphenadrine citrate 25 MG / aspirin 385 MG / caffeine 30 MG Oral Tablet	PSN	be2761bc-e537-4039-846a-2ffa3d8b2afc	3
994530	aspirin 385 MG / caffeine 30 MG / orphenadrine citrate 25 MG Oral Tablet [Norgesic]	SBD	be2761bc-e537-4039-846a-2ffa3d8b2afc	3
994528	aspirin 385 MG / caffeine 30 MG / orphenadrine citrate 25 MG Oral Tablet	SCD	be2761bc-e537-4039-846a-2ffa3d8b2afc	3
994528	ASA 385 MG / Caffeine 30 MG / Orphenadrine Citrate 25 MG Oral Tablet	SY	be2761bc-e537-4039-846a-2ffa3d8b2afc	3
994530	ASA 385 MG / Caffeine 30 MG / Orphenadrine Citrate 25 MG Oral Tablet [Norgesic]	SY	be2761bc-e537-4039-846a-2ffa3d8b2afc	3
994530	Norgesic 25/385/30 (orphenadrine / aspirin / caffeine) Oral Tablet	SY	be2761bc-e537-4039-846a-2ffa3d8b2afc	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61825-305-60	61825030560	60 TABLET in 1 BOTTLE, PLASTIC (61825-305-60)	60 tablet	2022-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Norgesic TM (orphenadrine citrate, aspirin and caffeine tablets)	Galt Pharmaceuticals, LLC	2026-01-08	HUMAN PRESCRIPTION DRUG LABEL	3