Bacteriostatic Water

Product NDC
0409-3977
11-digit product format
004093977
Labeler code
0409
Product ID
0409-3977_e421caa9-6011-4cdf-a16c-6fe96d8b958a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bacteriostatic Water
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hospira, Inc.
Application
NDA018802
Marketing category
NDA
Marketing start
2005-04-30
Substance
WATER
Active strength
1 mL/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 42.

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
N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINERSTERILE WATER FOR INJECTION100%LIQUID / N/AAPRLD, RS1982-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018802-001AP

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-273f01610625f2…
2019-09-15 20:21 UTC2019-09N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27b00525d2431f…
2019-07-19 19:46 UTC2019-07N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-273f0d92c62455…
2023-05-13 08:27 UTC2023-05N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27053a50430f4f…
2023-01-26 05:58 UTC2023-01N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018802-001BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER100%LIQUID / N/AAPRLD, RS1982-10-27e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018802-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018802-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018802-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018802-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018802-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018802-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018802-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018802-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018802-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018802-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018802-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018802-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018802-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018802-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018802-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018802-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018802-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018802-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018802-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018802-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018802-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018802-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N018802-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018802-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018802-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018802-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09N018802-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018802-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018802-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018802-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018802-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018802-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018802-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018802-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018802-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018802-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018802-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018802-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018802-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018802-001AP1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WATER1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
059QF0KO0RInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87d6e9dc-fe3b-4593-ac9a-d7493d1959c7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd59cd9-c847-4812-bf4a-c404905392f8Product name120260108
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-3977-01Bacteriostatic Water30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION3019
0409-3977-03Bacteriostatic Water25 in 1 TRAYINJECTION, SOLUTION2519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-3977-01ML - Milliliter0409-3977dc4783b8-78a0-49ff-a186-538a967f090f12015-04-03
0409-3977-03ML - Milliliter0409-39772235b13d-bd7c-4158-8541-eddee9e9063112012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-3977BACTERIOSTATIC WATER INJECTION, SOLUTION [HOSPIRA, INC.]19Current NDC, Legacy NDC, 2 package rows20241207_87d6e9dc-fe3b-4593-ac9a-d7493d1959c7.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 018802
application number: NDA018802
ndc (product): 0409-3977
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 018802
application number: NDA018802
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 018802
application number: NDA018802
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
application applno (NDA): 018802
application number: NDA018802
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 018802
application number: NDA018802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719316EGRIFTA WR 11.6 MG InjectionPSN839334d3-8c1d-4c26-9036-2ab524a6ea751
2719314tesamorelin 11.6 MG InjectionPSN839334d3-8c1d-4c26-9036-2ab524a6ea751
2719316tesamorelin 11.6 MG Injection [Egrifta]SBD839334d3-8c1d-4c26-9036-2ab524a6ea751
2719314tesamorelin 11.6 MG InjectionSCD839334d3-8c1d-4c26-9036-2ab524a6ea751
2719316Egrifta 11.6 MG InjectionSY839334d3-8c1d-4c26-9036-2ab524a6ea751
2719314tesamorelin 11.6 MG (as tesamorelin acetate 11.9 MG) InjectionSY839334d3-8c1d-4c26-9036-2ab524a6ea751

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0409-3977-010040939770130 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
0409-3977-030040939770325 VIAL, MULTI-DOSE in 1 TRAY (0409-3977-03) / 30 mL in 1 VIAL, MULTI-DOSE (0409-3977-01) 2005-04-300000-00-00NoNoCurrent