Lincomycin hydrochloride

Product NDC: 68083-479
11-digit product format: 680830479
Labeler code: 68083
Product ID: 68083-479_084e1826-51be-4e48-aae4-b6affb80853f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lincomycin hydrochloride
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL
Labeler: Gland Pharma Limited
Application: ANDA215657
Marketing category: ANDA
Marketing start: 2022-09-26
Substance: LINCOMYCIN HYDROCHLORIDE
Active strength: 300 mg/mL
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 42.

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
A215657-001	LINCOMYCIN HYDROCHLORIDE	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP		2022-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215657-001	AP

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215657-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2022-09-26	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A215657-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215657-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215657-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215657-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215657-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215657-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215657-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215657-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215657-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215657-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215657-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215657-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215657-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215657-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215657-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215657-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215657-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215657-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215657-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215657-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215657-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215657-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215657-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215657-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215657-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215657-001	AP	1	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215657-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LINCOMYCIN HYDROCHLORIDE	300 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
M6T05Z2B68	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
239212	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
c2b5be20-cc6f-4221-9d3e-3f8b5886cd05	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
673b6365-42b3-455d-b9d1-7358f1db4536	Product name	4	20231212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68083-479-01	Lincomycin hydrochloride	10 mL in 1 VIAL	INJECTION, SOLUTION	10		5
68083-479-01	Lincomycin hydrochloride	1 in 1 CARTON	INJECTION, SOLUTION	1		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68083-479	LINCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION LINCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20220929_c2b5be20-cc6f-4221-9d3e-3f8b5886cd05.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
Lincomycin	LINCOMYCIN HYDROCHLORIDE	Sagent Pharmaceuticals	75e149cc-b668-427e-bae7-a0d215e4fb7a	2023-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215657 application number: ANDA215657
lincomycin hydrochloride	LINCOMYCIN HYDROCHLORIDE	Gland Pharma Limited	c2b5be20-cc6f-4221-9d3e-3f8b5886cd05	2022-09-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215657 application number: ANDA215657 ndc (product): 68083-479

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
M6T05Z2B68	LINCOMYCIN HYDROCHLORIDE	7179-49-9	LINCOMYCIN HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
239212	lincomycin 300 MG/ML Injectable Solution	PSN	c2b5be20-cc6f-4221-9d3e-3f8b5886cd05	5
239212	lincomycin 300 MG/ML Injectable Solution	SCD	c2b5be20-cc6f-4221-9d3e-3f8b5886cd05	5
239212	lincomycin (as lincomycin HCl) 300 MG/ML Injectable Solution	SY	c2b5be20-cc6f-4221-9d3e-3f8b5886cd05	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68083-479-01	68083047901	1 VIAL in 1 CARTON (68083-479-01) / 10 mL in 1 VIAL	1 vial	2022-09-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lincomycin Injection, USP Sterile Solution for Intramuscular and Intravenous Use	Gland Pharma Limited	2022-09-28	Human Prescription Drug Label	5