LEVOTHYROXINE SODIUM

Product NDC: 31722-288
11-digit product format: 317220288
Labeler code: 31722
Product ID: 31722-288_7c79df0b-836b-479b-a7a6-8e09b802a84e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: levothyroxine sodium
Dosage form: TABLET
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA215259
Marketing category: ANDA
Marketing start: 2023-01-18
Substance: LEVOTHYROXINE SODIUM
Active strength: .1 mg/1
Pharmacologic classes: Thyroxine [CS], l-Thyroxine [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 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215259-001	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18
A215259-002	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18
A215259-003	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18
A215259-004	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18
A215259-005	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18
A215259-006	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18
A215259-007	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18
A215259-008	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18
A215259-009	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18
A215259-010	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18
A215259-011	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18
A215259-012	LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 12 matching rows.

Application-product, TE code table
Application-product	TE code
A215259-001	AB4
A215259-002	AB4
A215259-003	AB4
A215259-004	AB4
A215259-005	AB4
A215259-006	AB4
A215259-007	AB4
A215259-008	AB4
A215259-009	AB4
A215259-010	AB4
A215259-011	AB4
A215259-012	AB4

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 7 · 276 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215259-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215259-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-005	LEVOTHYROXINE SODIUM	0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-006	LEVOTHYROXINE SODIUM	0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-007	LEVOTHYROXINE SODIUM	0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-008	LEVOTHYROXINE SODIUM	0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-009	LEVOTHYROXINE SODIUM	0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-010	LEVOTHYROXINE SODIUM	0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-011	LEVOTHYROXINE SODIUM	0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-012	LEVOTHYROXINE SODIUM	0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215259-001	LEVOTHYROXINE SODIUM	0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215259-002	LEVOTHYROXINE SODIUM	0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215259-003	LEVOTHYROXINE SODIUM	0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215259-004	LEVOTHYROXINE SODIUM	0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET / ORAL	AB4	2023-01-18	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 276 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215259-001	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-002	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-003	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-004	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-005	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-006	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-007	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-008	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-009	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-010	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-011	AB4	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215259-012	AB4	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-001	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-002	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-003	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-004	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-005	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-006	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-007	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-008	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-009	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-010	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-011	AB4	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215259-012	AB4	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215259-001	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-002	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-003	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-004	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-005	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-006	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-007	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-008	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-009	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-010	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-011	AB4	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215259-012	AB4	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215259-001	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215259-002	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215259-003	AB4	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215259-004	AB4	1	`fd3edfee7708…`

Additional Listing Data#

Finished product: Yes
Brand name base: LEVOTHYROXINE SODIUM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOTHYROXINE SODIUM	.1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9J765S329G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
892246	Internal RxNorm lookup
892251	Internal RxNorm lookup
892255	Internal RxNorm lookup
966220	Internal RxNorm lookup
966221	Internal RxNorm lookup
966222	Internal RxNorm lookup
966224	Internal RxNorm lookup
966225	Internal RxNorm lookup
966248	Internal RxNorm lookup
966249	Internal RxNorm lookup
966253	Internal RxNorm lookup
966270	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
b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
97c252d3-9bb8-4530-bb44-9824dc7cf556	Product name	6	20250729
6c43b71c-35e6-4db3-ba24-c6ef42ff7003	Product name	3	20240207
890fd4bf-1a80-42b7-be1b-2d0259d5f0c8	Product name	5	20240207
c8ad26bf-af73-460b-b74e-1eff16cc4f9f	Product name	5	20240207
01383843-4069-43cf-aa76-dc17a6f9f8c4	Product name	2	20230123
978cca7d-a938-4791-8322-da48d90a63ef	Product name	1	20230113
65f86ba3-8816-4e12-899b-18290c8de551	Product name	2	20210614
f16ab90f-08c2-40be-a543-66d9827cd1f3	Product name	1	20210601
6a33ec05-2ae2-45e5-ab82-2d94b3303923	Product name	1	20190709
93355a10-1c44-4c92-a11d-7d995e0200d9	Product name	1	20190219

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
31722-288-01	LEVOTHYROXINE SODIUM	100 in 1 BOTTLE	TABLET	100	1
31722-288-10	LEVOTHYROXINE SODIUM	1000 in 1 BOTTLE	TABLET	1000	1
31722-288-30	LEVOTHYROXINE SODIUM	30 in 1 BOTTLE	TABLET	30	1
31722-288-90	LEVOTHYROXINE SODIUM	90 in 1 BOTTLE	TABLET	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-288-10	EA - Each	31722-288	a04c7ec5-5262-4d84-8586-27290f7a4af2	1	2023-04-07
31722-288-90	EA - Each	31722-288	2a5e7adf-96fb-4788-b0fe-8815737f46e4	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-288	LEVOTHYROXINE SODIUM TABLET [CAMBER PHARMACEUTICALS, INC.]	1	Current NDC, 4 package rows	20230124_b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	XLCare Pharmaceuticals, Inc.	51a27110-e787-409b-98ba-c6471d0ad5cf	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215259 application number: ANDA215259
LEVOTHYROXINE SODIUM	LEVOTHYROXINE SODIUM	Camber Pharmaceuticals, Inc.	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	2023-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215259 application number: ANDA215259 ndc (product): 31722-288

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9J765S329G	LEVOTHYROXINE SODIUM	6106-07-6	LEVOTHYROXINE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
892246	levothyroxine sodium 100 MCG Oral Tablet	PSN	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966248	levothyroxine sodium 112 MCG Oral Tablet	PSN	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966224	levothyroxine sodium 125 MCG Oral Tablet	PSN	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966270	levothyroxine sodium 137 MCG Oral Tablet	PSN	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966225	levothyroxine sodium 150 MCG Oral Tablet	PSN	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966249	levothyroxine sodium 175 MCG Oral Tablet	PSN	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
892251	levothyroxine sodium 200 MCG Oral Tablet	PSN	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966220	levothyroxine sodium 25 MCG Oral Tablet	PSN	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
892255	levothyroxine sodium 300 MCG Oral Tablet	PSN	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966221	levothyroxine sodium 50 MCG Oral Tablet	PSN	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966222	levothyroxine sodium 75 MCG Oral Tablet	PSN	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966253	levothyroxine sodium 88 MCG Oral Tablet	PSN	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966220	levothyroxine sodium 0.025 MG Oral Tablet	SCD	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966221	levothyroxine sodium 0.05 MG Oral Tablet	SCD	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966222	levothyroxine sodium 0.075 MG Oral Tablet	SCD	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966253	levothyroxine sodium 0.088 MG Oral Tablet	SCD	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
892246	levothyroxine sodium 0.1 MG Oral Tablet	SCD	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966248	levothyroxine sodium 0.112 MG Oral Tablet	SCD	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966224	levothyroxine sodium 0.125 MG Oral Tablet	SCD	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966270	levothyroxine sodium 0.137 MG Oral Tablet	SCD	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966225	levothyroxine sodium 0.15 MG Oral Tablet	SCD	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966249	levothyroxine sodium 0.175 MG Oral Tablet	SCD	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
892251	levothyroxine sodium 0.2 MG Oral Tablet	SCD	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
892255	levothyroxine sodium 0.3 MG Oral Tablet	SCD	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
892246	levothyroxine sodium 100 MCG Oral Tablet	SY	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966248	levothyroxine sodium 112 MCG Oral Tablet	SY	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966224	levothyroxine sodium 125 MCG Oral Tablet	SY	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966270	levothyroxine sodium 137 MCG Oral Tablet	SY	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966225	levothyroxine sodium 150 MCG Oral Tablet	SY	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966249	levothyroxine sodium 175 MCG Oral Tablet	SY	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
892251	levothyroxine sodium 200 MCG Oral Tablet	SY	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966220	levothyroxine sodium 25 MCG Oral Tablet	SY	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
892255	levothyroxine sodium 300 MCG Oral Tablet	SY	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966221	levothyroxine sodium 50 MCG Oral Tablet	SY	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966222	levothyroxine sodium 75 MCG Oral Tablet	SY	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1
966253	levothyroxine sodium 88 MCG Oral Tablet	SY	b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
31722-288-01	31722028801	100 TABLET in 1 BOTTLE (31722-288-01)	100 tablet	2023-01-18	No	No	Current
31722-288-10	31722028810	1000 TABLET in 1 BOTTLE (31722-288-10)	1000 tablet	2023-01-18	No	No	Current
31722-288-30	31722028830	30 TABLET in 1 BOTTLE (31722-288-30)	30 tablet	2023-01-18	No	No	Current
31722-288-90	31722028890	90 TABLET in 1 BOTTLE (31722-288-90)	90 tablet	2023-01-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LEVOTHYROXINE SODIUM	Camber Pharmaceuticals, Inc. \| Ascent Pharmaceuticals, Inc	2023-01-23	HUMAN PRESCRIPTION DRUG LABEL	1