Sunmark Loratadine

Product NDC: 49348-818
11-digit product format: 493480818
Labeler code: 49348
Product ID: 49348-818_b14990f8-9e84-4d8a-8e28-a9f2271254f7
Type: HUMAN OTC DRUG
Nonproprietary name: Loratadine
Dosage form: TABLET
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA076301
Marketing category: ANDA
Marketing start: 2007-06-21
Marketing end: 0000-00-00
Substance: LORATADINE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49348-818		D	Discontinued by firm	2026-10-05
excluded package	package	49348-818	49348-818-01	D	Discontinued by firm	2026-10-05
excluded package	package	49348-818	49348-818-12	D	Discontinued by firm	2026-10-05
excluded package	package	49348-818	49348-818-13	D	Discontinued by firm	2026-10-05
excluded package	package	49348-818	49348-818-44	D	Discontinued by firm	2026-10-05
excluded package	package	49348-818	49348-818-45	D	Discontinued by firm	2026-10-05
excluded package	package	49348-818	49348-818-56	D	Discontinued by firm	2026-10-05

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-818-44	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-818-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-818-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-818-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-818-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-818-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-818-44	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-818-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-818-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-818-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-818-56	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-818-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-818-44	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-818-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-818-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-818-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-818-56	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-818-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-818-44	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-818-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-818-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-818-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-818-56	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-818-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-818-44	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-818-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-818-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-818-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-818-56	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-818-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-818-44	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-818-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-818-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-818-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-818-56	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-818-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-818-44	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-818-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-818-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-818-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-818-56	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-818-45	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-818-44	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-818-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-818-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-818-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-818-56	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-818-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-818-44	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-818-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-818-01	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076301-001	LORATADINE	LORATADINE	10MG	TABLET / ORAL			2004-06-25

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076301-001	LORATADINE	10MG	TABLET / ORAL	2004-06-25	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49348-818-01	EA - Each	49348-818	e3e07d67-117e-4cec-93a7-c4f71e674496	1	2012-07-24
49348-818-12	EA - Each	49348-818	e85e0350-e977-4f1a-bd46-8cdb459cea2c	1	2012-07-24
49348-818-13	EA - Each	49348-818	2aca27b0-cbc4-4b22-ab9d-a8e1d00120d7	1	2012-07-24
49348-818-44	EA - Each	49348-818	aa5b2f9a-e0fb-4734-bf33-639b3b0916bb	1	2012-07-24
49348-818-45	EA - Each	49348-818	32784982-ba25-46e4-8c81-af78cc64ad2e	1	2019-02-13
49348-818-56	EA - Each	49348-818	5a9bc438-e126-4e6b-8cf6-53aaa2ce9f23	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	SUNMARK LORATADINE (LORATADINE) TABLET [MCKESSON]	3
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	SUNMARK LORATADINE (LORATADINE) TABLET [MCKESSON]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SUNMARK LORATADINE (LORATADINE) TABLET [MCKESSON]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SUNMARK LORATADINE (LORATADINE) TABLET [MCKESSON]	3
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	SUNMARK LORATADINE (LORATADINE) TABLET [MCKESSON]	3

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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leader Allergy Relief	LORATADINE	Cardinal Health 110, LLC. dba Leader	6f5134c6-ece6-4e35-a0c3-13e0dfa173fa	2025-04-01	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
up and up allergy relief	LORATADINE	Target Corporation	c4ef0110-89c3-4ded-9a9a-75c0f794f869	2025-03-28	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
TopCare Allergy Relief 24 hour	LORATADINE	Topco Associates LLC	a500aebf-a020-4da9-afdb-a699077cb8e1	2025-03-28	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	NuCare Pharmaceuticals,Inc.	fc63689e-e449-ca8f-e053-6394a90a54a2	2025-02-05	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	NuCare Pharmaceuticals,Inc.	54b37bcc-a8b0-0c17-e054-00144ff8d46c	2025-01-09	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
foster and thrive allergy relief	LORATADINE	Strategic Sourcing Services LLC	aff1ab34-51b0-488c-931e-c95aad226572	2024-12-11	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good neighbor pharmacy loratadine	LORATADINE	Amerisource Bergen	9dda0f0b-fbab-47ee-8db8-95bd126fc61c	2024-12-11	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
exchange select allergy relief	LORATADINE	Army & Air Force Exchange Service	ea5622d9-4e71-4a1f-9200-6b4cecac1215	2024-12-02	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	A-S Medication Solutions	9cc3d50a-81ce-4c9d-9721-209169a332e0	2024-08-21	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
allergy relief	LORATADINE	Meijer Distribution Inc	9261a02b-db43-462f-9f06-fb5624070e20	2024-08-06	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	Aphena Pharma Solutions - Tennessee, LLC	a2c92766-df4e-4414-9c42-e18bcf9db6b4	2024-04-09	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	A-S Medication Solutions	c288d849-59c9-4883-aac4-bae54acee8ac	2024-03-27	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
members mark allergy relief	LORATADINE	Sam's West Inc	95c2b45a-d0e5-467c-aad4-7bbb6c9a5204	2024-03-11	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
good sense allergy relief	LORATADINE	A-S Medication Solutions	5fda4906-4133-4293-8b39-4ddcf8d39801	2024-02-04	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
kirkland signature allerclear	LORATADINE	Costco Wholesale Company	2074d52e-8c0a-4e69-bfb1-864ffc07e25f	2024-01-17	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
equate allergy relief	LORATADINE	Wal-Mart Stores Inc	dd36dc43-a9b7-4cda-86e0-9283d996a60a	2022-12-05	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
basic care allergy relief	LORATADINE	Amazon.com Services LLC	a4a7f024-972b-4a16-9cb8-28954c2a74c6	2022-10-18	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine antihistamine	LORATADINE	Proficient Rx LP	e9b87f79-ebed-4677-8e50-00cb4282ee56	2022-04-01	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
welby all day allergy relief	LORATADINE	Aldi, Inc	efe2fa11-8115-4d33-bb32-8e2509839ef4	2021-06-22	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301
Loratadine	LORATADINE	Aphena Pharma Solutions - Tennessee, LLC	8ffe2faf-3253-4121-a069-6f46e319c6f0	2020-05-13	Warnings	Exact identifier application applno (ANDA): 076301 application number: ANDA076301

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7AJO3BO7QN	LORATADINE	79794-75-5	LORATADINE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49348-818-01	49348081801	10 BLISTER PACK in 1 CARTON (49348-818-01) > 1 TABLET in 1 BLISTER PACK	10 blister pack	2007-06-25	0000-00-00	No	No	Current
49348-818-13	49348081813	1 BOTTLE in 1 CARTON (49348-818-13) > 90 TABLET in 1 BOTTLE	1 bottle	2007-06-21	0000-00-00	No	No	Current
49348-818-44	49348081844	30 BLISTER PACK in 1 CARTON (49348-818-44) > 1 TABLET in 1 BLISTER PACK	30 blister pack	2007-06-21	0000-00-00	No	No	Current
49348-818-45	49348081845	1 BOTTLE in 1 CARTON (49348-818-45) > 30 TABLET in 1 BOTTLE	1 bottle	2018-10-24	0000-00-00	No	No	Current
49348-818-56	49348081856	1 BOTTLE in 1 CARTON (49348-818-56) > 70 TABLET in 1 BOTTLE	1 bottle	2014-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
McKesson Loratadine Tablets 10 mg Drug Facts	A-S Medication Solutions	2023-02-06	HUMAN OTC DRUG LABEL	3
McKesson Loratadine Tablets 10 mg Drug Facts	Strategic Sourcing Services LLC	2020-03-25	HUMAN OTC DRUG LABEL	7