Application 212542

Type: ANDA
Sponsor: SUN PHARM INDS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	600MG;60MG	No	No
002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.2GM;120MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL			2020-04-28
A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL			2020-04-28

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 · 74 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	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212542-001	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	600MG;60MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212542-002	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	1.2GM;120MG	TABLET, EXTENDED RELEASE / ORAL	2020-04-28	`87673890dc5c…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guaifenesin D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	RUGBY LABORATORIES, INC.	997946e6-eff0-4c15-8694-020a19c2d336	2026-05-06	Warnings	Exact identifier application applno (ANDA): 212542 application number: ANDA212542 ndc (product): 0536-1333
Guaifenesin and Pseudoephedrine HCl	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Strategic Sourcing Services LLC	27f85134-cd38-b33c-e063-6394a90a05a8	2024-11-28	Warnings	Exact identifier application applno (ANDA): 212542 application number: ANDA212542
Guaifenesin and Pseudoephedrine HCl	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Ohm Laboratories, Inc.	2521ecd3-28f3-a13c-e063-6394a90a7245	2024-10-23	Warnings	Exact identifier application applno (ANDA): 212542 application number: ANDA212542
MAXIMUM STRENGTH Mucus D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	9a560b80-972c-4af5-8fe8-eaef0b0d83b3	2022-12-01	Warnings	Exact identifier application applno (ANDA): 212542 application number: ANDA212542 ndc (product): 51316-970
Guaifenesin D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Walgreen Company	abecb791-b635-482f-bb99-3ee4b7093e78	2022-06-24	Warnings	Exact identifier application applno (ANDA): 212542 application number: ANDA212542 ndc (product): 0363-9930
Guaifenesin D	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy, Inc.	4dee850b-b170-4ef9-ae02-3db9bfa05abe	2022-06-08	Warnings	Exact identifier application applno (ANDA): 212542 application number: ANDA212542 ndc (product): 51316-993
Guaifenesin and Pseudoephedrine Hydrochloride	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	PUBLIX SUPER MARKETS, INC	c857bcd9-6696-40d5-93c0-65097598cd4b	2022-04-08	Warnings	Exact identifier application applno (ANDA): 212542 application number: ANDA212542 ndc (product): 41415-994
Guaifenesin and Pseudoephedrine Hydrochloride	GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	d139fd8d-66fd-4484-8e78-ed90c505d999	2022-02-08	Warnings	Exact identifier application applno (ANDA): 212542 application number: ANDA212542 ndc (product): 62011-0475

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0363-9930	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	Walgreen Company	ANDA	Current
0536-1333	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	RUGBY LABORATORIES, INC.	ANDA	Current
0536-1333	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	RUGBY LABORATORIES, INC.	ANDA	Current
41415-994	Guaifenesin and Pseudoephedrine Hydrochloride	Guaifenesin and Pseudoephedrine Hydrochloride	PUBLIX SUPER MARKETS, INC	ANDA	Current
51316-970	MAXIMUM STRENGTH Mucus D	guaifenesin and pseudoephedrine hydrochloride	CVS Pharmacy	ANDA	Current
51316-993	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	CVS Pharmacy, Inc.	ANDA	Current
51316-993	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	CVS Pharmacy, Inc.	ANDA	Current
51316-993	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	CVS Pharmacy, Inc.	ANDA	Current
51660-057	Guaifenesin and Pseudoephedrine HCl	Guaifenesin and Pseudoephedrine HCl	Ohm Laboratories, Inc.	ANDA	Current
51660-058	Guaifenesin and Pseudoephedrine HCl	Guaifenesin and Pseudoephedrine HCl	Ohm Laboratories, Inc.	ANDA	Current
62011-0475	Guaifenesin and Pseudoephedrine Hydrochloride	Guaifenesin and Pseudoephedrine Hydrochloride	STRATEGIC SOURCING SERVICES LLC	ANDA	Current
70000-0580	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	CARDINAL HEALTH 110, LLC. DBA LEADER	ANDA	Current
70000-0580	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	CARDINAL HEALTH 110, LLC. DBA LEADER	ANDA	Current
70000-0580	Guaifenesin D	Guaifenesin and Pseudoephedrine Hydrochloride	CARDINAL HEALTH 110, LLC. DBA LEADER	ANDA	Current