Lincomycin

Product NDC: 0121-1035
11-digit product format: 001211035
Labeler code: 0121
Product ID: 0121-1035_23f95ea6-ad32-a143-e063-6394a90ae77c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lincomycin Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: ANDA212770
Marketing category: ANDA
Marketing start: 2024-10-07
Substance: LINCOMYCIN HYDROCHLORIDE
Active strength: 3000 mg/10mL
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
A212770-001	LINCOMYCIN HYDROCHLORIDE	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP		2021-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212770-001	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	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION		2021-03-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212770-001	LINCOMYCIN HYDROCHLORIDE	EQ 300MG BASE/ML	INJECTABLE / INJECTION	AP	2021-03-12	`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	A212770-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212770-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212770-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212770-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212770-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212770-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212770-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212770-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212770-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212770-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212770-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212770-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212770-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212770-001	AP	1	`1e350fbaab3a…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212770-001	AP	1	`87673890dc5c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212770-001	AP	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LINCOMYCIN HYDROCHLORIDE	3000 mg/10mL

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
23f9608c-3126-35db-e063-6294a90af054	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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0121-1035-55	Lincomycin	10 mL in 1 VIAL, MULTI-DOSE	INJECTION	10		1
0121-1035-55	Lincomycin	10 in 1 CARTON	INJECTION	10		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-1035-55	ML - Milliliter	0121-1035	9e1c4c33-1434-4535-99c8-666720ed2dd0	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-1035	LINCOMYCIN (LINCOMYCIN HYDROCHLORIDE) INJECTION [PAI HOLDINGS, LLC DBA PAI PHARMA]	1	Current NDC, 2 package rows	20241010_23f9608c-3126-35db-e063-6294a90af054.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lincomycin	LINCOMYCIN HYDROCHLORIDE	PAI Holdings, LLC dba PAI Pharma	23f9608c-3126-35db-e063-6294a90af054	2024-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212770 application number: ANDA212770 ndc (product): 0121-1035

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	23f9608c-3126-35db-e063-6294a90af054	1
239212	lincomycin 300 MG/ML Injectable Solution	SCD	23f9608c-3126-35db-e063-6294a90af054	1
239212	lincomycin (as lincomycin HCl) 300 MG/ML Injectable Solution	SY	23f9608c-3126-35db-e063-6294a90af054	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0121-1035-55	00121103555	10 VIAL, MULTI-DOSE in 1 CARTON (0121-1035-55) / 10 mL in 1 VIAL, MULTI-DOSE	2024-10-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lincomycin Injection, USP Rx only	PAI Holdings, LLC dba PAI Pharma \| Arthur Group, LLC	2024-10-08	HUMAN PRESCRIPTION DRUG LABEL	1