Pseudoephedrine hydrochloride

Product NDC: 70518-3405
11-digit product format: 705183405
Labeler code: 70518
Product ID: 70518-3405_dc270f0e-066d-6853-e053-2a95a90ae6b8
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA077442
Marketing category: ANDA
Marketing start: 2022-04-07
Marketing end: 0000-00-00
Substance: PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 120 mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	70518-3405		D	Discontinued by firm		2026-08-03
excluded package	package	70518-3405	70518-3405-0	D	Discontinued by firm		2026-08-03

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
A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL			2005-09-28

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`cb3db0bc1861…`
2026-08-01 22:54:32	2026-06	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	3bf95c58-4fd9-4caa-a54f-2e61a5eacae8	2026-05-06	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Sportpharm LLC	3b5c81b7-7464-129f-e063-6294a90a48c0	2026-02-06	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	A-S Medication Solutions	0a2672f0-4e6f-48c9-8571-2d09f06253d7	2026-01-29	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Major Pharmaceuticals	658b0fe8-d564-4f79-bbb2-939c518651b7	2024-06-18	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
12 Hour Nasal Decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	CARDINAL HEALTH	0ec510e8-a8cf-474b-9da4-2ac5122d6b49	2024-05-20	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Ohm Laboratories Inc.	4e98dd9f-4ab9-4d95-95b0-799ce217da70	2024-01-18	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Walgreen Company	e33d6ca8-7b3c-42ad-85d3-3302a949501e	2022-05-18	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	CARDINAL HEALTH 110, LLC DBA LEADER	a2189d7d-9335-4e96-8f6d-95c583739ac0	2022-05-12	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	The Kroger Company	00a8327b-41f0-4498-ad13-331256b539f9	2021-04-13	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	918b2a90-532b-4358-bdff-9ad48c167a7e	2020-08-11	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
nasal decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Strategic Sourcing Services	53acd8d9-b9d8-4a38-8597-32043548d832	2020-07-01	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	HEB	d9b46ff2-8bde-47c0-bc63-b19dbe7e197b	2019-05-29	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Ohm Laboratories Inc.	f398ceab-e3d2-421d-813e-b66369f65472	2019-05-01	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	3a3d11e5-ebbf-4356-8ae6-4e5656b5644c	2019-04-10	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Chain Drug Consortium, LLC	aec6412a-b62c-44c8-84f5-77f5fa441028	2019-04-10	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	SAM'S WEST INC	5a885a10-7751-44f1-b2d9-a918f27604df	2019-03-29	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	DISCOUNT DRUG MART	7668ad20-1ca7-4d93-b3a3-03cfde141f86	2019-03-19	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Safeway Inc.	01a5d9dd-f123-443b-b968-412c0aadaaa2	2019-03-14	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Chain Drug Marketing Association Inc.	880d368f-0ce3-4993-b5b1-13bf01310516	2019-03-14	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442
Pseudoephedrine Hydrochloride	PSEUDOEPHEDRINE HYDROCHLORIDE	Publix Super Markets Inc	9a6ece8b-7036-4cad-aeb3-993ef4bf614f	2019-03-14	Warnings	Exact identifier application applno (ANDA): 077442 application number: ANDA077442

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3405-0	70518340500	10 TABLET, FILM COATED in 1 BLISTER PACK (70518-3405-0)	2022-04-07	0000-00-00	No	No	Current

Pseudoephedrine hydrochloride

NDC auxiliary status#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#