Methocarbamol and Aspirin

Product NDC: 50564-490
11-digit product format: 505640490
Labeler code: 50564
Product ID: 50564-490_518282ce-77df-411f-85d4-ada698987b2c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methocarbamol and Aspirin
Dosage form: TABLET
Route: ORAL
Labeler: Jerome Stevens Pharmaceuticals, Inc.
Application: ANDA081145
Marketing category: ANDA
Marketing start: 1995-01-31
Marketing end: 0000-00-00
Substance: METHOCARBAMOL; ASPIRIN
Active strength: 400 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]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50564-490		I	Inactivated by FDA	2026-08-07
excluded package	package	50564-490	50564-490-01	I	Inactivated by FDA	2026-08-07
excluded package	package	50564-490	50564-490-05	I	Inactivated by FDA	2026-08-07

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 · 18 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
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	50564-490-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50564-490-01	`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	50564-490-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50564-490-01	`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	50564-490-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50564-490-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50564-490-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50564-490-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50564-490-05	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50564-490-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50564-490-05	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50564-490-01	`1332a3947898…`	`d4bfe170f9cd…`

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
A081145-001	METHOCARBAMOL AND ASPIRIN	ASPIRIN; METHOCARBAMOL	325MG;400MG	TABLET / ORAL			1995-01-31

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	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL	RS	1995-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL	RS	1995-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL	RS	1995-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL	RS	1995-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A081145-001	METHOCARBAMOL AND ASPIRIN	325MG;400MG	TABLET / ORAL		1995-01-31	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
492965be-47bc-38cf-57c4-5c5e0343abe5	Product name	6	20211028
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
02a01e9c-3f4e-c0ee-6542-be865127aea3	Product name	8	20190205
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50564-490-01	2026-01-29	Methocarbamol and Aspirin Tablets
50564-490-05	2026-01-29	Methocarbamol and Aspirin Tablets
50564-490-01	2024-12-05	Methocarbamol and Aspirin Tablets
50564-490-05	2024-12-05	Methocarbamol and Aspirin Tablets
50564-490-01	2023-01-30	Methocarbamol and Aspirin Tablets
50564-490-05	2023-01-30	Methocarbamol and Aspirin Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50564-490-01	Methocarbamol and Aspirin	100 in 1 BOTTLE	TABLET	100		4
50564-490-05	Methocarbamol and Aspirin	500 in 1 BOTTLE	TABLET	500		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50564-490	METHOCARBAMOL AND ASPIRIN TABLET [JEROME STEVENS PHARMACEUTICALS, INC.]	4	Legacy NDC, 2 package rows	20241207_055edd83-bab7-486a-a2b8-dad9f3bae916.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
125OD7737X	METHOCARBAMOL	532-03-6	METHOCARBAMOL
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197945	methocarbamol 400 MG / aspirin 325 MG Oral Tablet	PSN	055edd83-bab7-486a-a2b8-dad9f3bae916	4
197945	aspirin 325 MG / methocarbamol 400 MG Oral Tablet	SCD	055edd83-bab7-486a-a2b8-dad9f3bae916	4
197945	ASA 325 MG / Methocarbamol 400 MG Oral Tablet	SY	055edd83-bab7-486a-a2b8-dad9f3bae916	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50564-490-01	50564049001	100 TABLET in 1 BOTTLE (50564-490-01)	100 tablet	1995-01-31	0000-00-00	No	No	Current
50564-490-05	50564049005	500 TABLET in 1 BOTTLE (50564-490-05)	500 tablet	1995-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methocarbamol and Aspirin Tablets	Jerome Stevens Pharmaceuticals, Inc.	2024-07-16	HUMAN PRESCRIPTION DRUG LABEL	4