Home NDC 70625-113-01 Lincomycin
Product NDC 70625-113
Requested package NDC 70625-113-01
11-digit product format 706250113
Labeler code 70625
Product ID 70625-113_be75b2cd-1337-6d22-e053-2995a90a23d2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lincomycin
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCONJUNCTIVAL
Labeler Praxgen Pharmaceuticals LLC
Application ANDA212770
Marketing category ANDA
Marketing start 2021-03-30
Marketing end 0000-00-00
Substance LINCOMYCIN HYDROCHLORIDE
Active strength 300 mg/mL
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 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 RLD / RS Approval date Source SHA-256 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# 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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70625-113-01 70625011301 1 VIAL in 1 CARTON (70625-113-01) > 10 mL in 1 VIAL 1 vial 2021-03-30 0000-00-00 No No Current