Pseudoephedrine Hydrochloride

Product NDC: 68016-204
11-digit product format: 680160204
Labeler code: 68016
Product ID: 68016-204_f73d7997-407d-4a93-99f5-0f2be115cc51
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Chain Drug Consortium, LLC
Application: ANDA077442
Marketing category: ANDA
Marketing start: 2006-04-28
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…`

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 ndc (product): 68016-204
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

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
aec6412a-b62c-44c8-84f5-77f5fa441028	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
68016-204-69	Pseudoephedrine Hydrochloride	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	3
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	3
CASTOR OIL	INACTIVE INGREDIENT	D5340Y2I9G	PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-204	PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	4	Current NDC, Legacy NDC, 1 package rows	20190412_aec6412a-b62c-44c8-84f5-77f5fa441028.zip

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	aec6412a-b62c-44c8-84f5-77f5fa441028	4
1049154	12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	aec6412a-b62c-44c8-84f5-77f5fa441028	4
1049154	pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet	SY	aec6412a-b62c-44c8-84f5-77f5fa441028	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-204-69	68016020469	10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68016-204-69)	2006-04-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pseudoephedrine Hydrochloride	Chain Drug Consortium, LLC \| Ohm Laboratories Inc.	2019-04-10	HUMAN OTC DRUG LABEL	4