Home NDC 42571-374-75 Lincomycin
Product NDC 42571-374
Requested package NDC 42571-374-75
11-digit product format 425710374
Labeler code 42571
Product ID 42571-374_e2cf9f04-64e0-4a9c-e053-2a95a90a25ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lincomycin
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Micro Labs Limited
Application ANDA215082
Marketing category ANDA
Marketing start 2022-02-01
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 1 .
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 A215082-001 LINCOMYCIN HYDROCHLORIDE LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215082-001 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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215082-001 LINCOMYCIN EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215082-001 LINCOMYCIN EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215082-001 LINCOMYCIN EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215082-001 LINCOMYCIN EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215082-001 LINCOMYCIN EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215082-001 LINCOMYCIN EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215082-001 LINCOMYCIN EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215082-001 LINCOMYCIN EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215082-001 LINCOMYCIN EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215082-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2021-11-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lincomycin
Listing expiration 2027-12-31 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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42571-374-75 Lincomycin 2 mL in 1 VIAL INJECTION, SOLUTION 2 13 42571-374-75 Lincomycin 1 in 1 CARTON INJECTION, SOLUTION 1 13 42571-374-88 Lincomycin 1 in 1 CARTON INJECTION, SOLUTION 1 13 42571-374-88 Lincomycin 10 mL in 1 VIAL INJECTION, SOLUTION 10 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-374 LINCOMYCIN (LINCOMYCIN) INJECTION, SOLUTION [MICRO LABS LIMITED] 13 Current NDC, Legacy NDC, 4 package rows 20220705_20c0e8af-a78f-47f8-ace4-06b80def7003.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42571-374-75 42571037475 1 VIAL in 1 CARTON (42571-374-75) / 2 mL in 1 VIAL 1 vial 2022-02-01 0000-00-00 No No Current