Streptomycin

Product NDC
39822-0706
11-digit product format
398220706
Labeler code
39822
Product ID
39822-0706_48eb47bf-4135-a8cf-e063-6394a90a4d2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Streptomycin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA064210
Marketing category
ANDA
Marketing start
1998-06-30
Substance
STREPTOMYCIN SULFATE
Active strength
1 g/1
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antimycobacterial [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A064210-001STREPTOMYCIN SULFATESTREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-303f01610625f2…
2019-09-15 20:21 UTC2019-09A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A064210-001STREPTOMYCIN SULFATEEQ 1GM BASE/VIALINJECTABLE / INJECTIONRS1998-06-30cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Streptomycin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STREPTOMYCIN SULFATE1 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CW25IKJ202Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313115Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
abd1f64e-4283-4370-aae8-3666316aa36eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-0706-1Streptomycin1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,115
39822-0706-2Streptomycin10 in 1 BOXINJECTION, POWDER, LYOPHILIZED,1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-0706-1EA - Each39822-07063fa3759d-8c20-448d-98d2-a5c16a0b032212012-07-24
39822-0706-2EA - Each39822-0706711ff110-f108-41a2-998c-ad2bc9d727cc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
STREPTOMYCIN SULFATEACTIVE INGREDIENTCW25IKJ202STREPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]8
STREPTOMYCINACTIVE MOIETYY45QSO73OBSTREPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-0706STREPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]13Current NDC, Legacy NDC, 2 package rows20230823_abd1f64e-4283-4370-aae8-3666316aa36e.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StreptomycinSTREPTOMYCINXGen Pharmaceuticals DJB, Inc.abd1f64e-4283-4370-aae8-3666316aa36e2026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064210
application number: ANDA064210
ndc (product): 39822-0706

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313115streptomycin 1 GM InjectionPSNabd1f64e-4283-4370-aae8-3666316aa36e15
313115streptomycin 1000 MG InjectionSCDabd1f64e-4283-4370-aae8-3666316aa36e15
313115streptomycin (as streptomycin sulfate) 1000 MG InjectionSYabd1f64e-4283-4370-aae8-3666316aa36e15
313115streptomycin 1 GM InjectionSYabd1f64e-4283-4370-aae8-3666316aa36e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-0706-1398220706011 in 1 VIALHistorical
39822-0706-23982207060210 VIAL in 1 BOX (39822-0706-2) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (39822-0706-1) 10 vial1998-06-300000-00-00NoNoCurrent