Home NDC 70436-035 lincomycin
Product NDC 70436-035
11-digit product format 704360035
Labeler code 70436
Product ID 70436-035_f79cdb51-41ca-2bb3-e053-6294a90abb15
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lincomycin
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA216662
Marketing category ANDA
Marketing start 2023-02-23
Substance LINCOMYCIN
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 A216662-001 LINCOMYCIN HYDROCHLORIDE LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21
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 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2022-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2022-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION AP 2022-12-21 3bdfa0b2c4d7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216662-001 LINCOMYCIN HYDROCHLORIDE EQ 300MG BASE/ML INJECTABLE / INJECTION 2022-12-21 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216662-001 AP 1 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216662-001 AP 1 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216662-001 AP 1 3bdfa0b2c4d7…
Additional Listing Data#
Finished product Yes
Brand name base lincomycin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LINCOMYCIN 300 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BOD072YW0F 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70436-035-80 lincomycin 10 mL in 1 VIAL INJECTION, SOLUTION 10 2 70436-035-80 lincomycin 1 in 1 CARTON INJECTION, SOLUTION 1 2 70436-035-82 lincomycin 10 in 1 CARTON INJECTION, SOLUTION 10 2 70436-035-82 lincomycin 10 mL in 1 VIAL INJECTION, SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-035 LINCOMYCIN INJECTION, SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] 2 Current NDC, Legacy NDC, 4 package rows 20230131_7efe038a-8d67-4151-864a-b4863b46643e.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.
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 70436-035-80 70436003580 1 VIAL in 1 CARTON (70436-035-80) / 10 mL in 1 VIAL 1 vial 2023-02-23 0000-00-00 No No Current 70436-035-82 70436003582 10 VIAL in 1 CARTON (70436-035-82) / 10 mL in 1 VIAL 10 vial 2023-02-23 0000-00-00 No No Current