Pseudoephedrine hydrochloride

Product NDC: 68196-204
11-digit product format: 681960204
Labeler code: 68196
Product ID: 68196-204_b22ca9ba-71ee-41a5-8395-85eeea13f4a4
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: SAM'S WEST INC
Application: ANDA077442
Marketing category: ANDA
Marketing start: 2012-02-07
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: 2026-12-31
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 · 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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077442-001	PSEUDOEPHEDRINE HYDROCHLORIDE	120MG	TABLET, EXTENDED RELEASE / ORAL	2005-09-28	`ea1830bbd6c7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pseudoephedrine hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049154	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
5a885a10-7751-44f1-b2d9-a918f27604df	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68196-204-20	Pseudoephedrine hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED	10		1
68196-204-20	Pseudoephedrine hydrochloride	2 in 1 PACKAGE	TABLET, FILM COATED	2		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68196-204	PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED [SAM'S WEST INC]	1	Current NDC, Legacy NDC, 2 package rows	20190409_5a885a10-7751-44f1-b2d9-a918f27604df.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 · 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 ndc (product): 68196-204
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049154	pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	5a885a10-7751-44f1-b2d9-a918f27604df	1
1049154	12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	5a885a10-7751-44f1-b2d9-a918f27604df	1
1049154	pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet	SY	5a885a10-7751-44f1-b2d9-a918f27604df	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68196-204-20	68196020420	2 BLISTER PACK in 1 PACKAGE (68196-204-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2012-02-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pseudoephedrine hydrochloride	SAM'S WEST INC \| Ohm Laboratories Inc.	2019-03-29	HUMAN OTC DRUG LABEL	1