Hyoscyamine

Product NDC: 75929-057
11-digit product format: 759290057
Labeler code: 75929
Product ID: 75929-057_347830a8-8833-26b7-e063-6294a90a1f17
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: hyoscyamine sulfate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Pharma Packaging Solutions, LLC dba Tjopack LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2016-05-01
Substance: HYOSCYAMINE SULFATE
Active strength: .375 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	75929-057		D	Discontinued by firm		2026-08-11
excluded package	package	75929-057	75929-057-10	D	Discontinued by firm		2026-08-11

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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75929-057-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75929-057-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75929-057-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75929-057-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	75929-057-10	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	75929-057-10	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	75929-057-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75929-057-10	2025-04-24	C162847	48780-1	2cef2736-9ebb-d83d-e063-dadaa90ab31f	Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg Rx only (Packaged by Pharma Packaging Solutions, LLC dba Tjoapack LLC)
75929-057-10	2025-01-30	C162847	48780-1	2cef2736-9ebb-d83d-e063-dadaa90ab31f	Hyoscyamine Sulfate Extended-Release Tablets, 0.375 mg Rx only (Packaged by Pharma Packaging Solutions, LLC dba Tjoapack LLC)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
75929-057-10	HyoscyamineER	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75929-057	HYOSCYAMINE ER (HYOSCYAMINE SULFATE) TABLET, EXTENDED RELEASE [PHARMA PACKAGING SOLUTIONS, LLC DBA TJOPACK LLC]	3	Current NDC, 1 package rows	20250507_01f97804-a6cb-ce6d-e063-6394a90ae220.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F2R8V82B84	HYOSCYAMINE SULFATE	6835-16-1	HYOSCYAMINE SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046770	hyoscyamine sulfate 0.375 MG 12HR Extended Release Oral Tablet	PSN	01f97804-a6cb-ce6d-e063-6394a90ae220	3
1046770	12 HR hyoscyamine sulfate 0.375 MG Extended Release Oral Tablet	SCD	01f97804-a6cb-ce6d-e063-6394a90ae220	3
1046770	hyoscyamine sulfate 0.375 MG 12 HR Extended Release Oral Tablet	SY	01f97804-a6cb-ce6d-e063-6394a90ae220	3
1046770	hyoscyamine sulfate 375 MCG 12 HR Extended Release Oral Tablet	SY	01f97804-a6cb-ce6d-e063-6394a90ae220	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
75929-057-10	75929005710	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (75929-057-10)	2016-05-01	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hyoscyamine ER	Pharma Packaging Solutions, LLC dba Tjopack LLC \| Sovereign Pharmaceuticals, LLC \| Pharma Packaging Solutions, LLC dba Tjoapack LLC	2025-05-06	HUMAN PRESCRIPTION DRUG LABEL	3