Vancocin

Product NDC
62559-310
11-digit product format
625590310
Labeler code
62559
Product ID
62559-310_25ea5560-90e4-4bba-a264-f8fec58bfc6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vancomycin hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA050606
Marketing category
NDA
Marketing start
2014-11-17
Substance
VANCOMYCIN HYDROCHLORIDE
Active strength
125 mg/1
Pharmacologic classes
Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050606-001VANCOCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-15
N050606-002VANCOCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N050606-001AB
N050606-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050606-001VANCOCIN HYDROCHLORIDEEQ 125MG BASECAPSULE / ORALABRLD1986-04-15782e0a99824c…
2021-12-28 21:50 UTC2021-12N050606-002VANCOCIN HYDROCHLORIDEEQ 250MG BASECAPSULE / ORALABRLD, RS1986-04-15782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050606-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050606-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050606-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050606-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050606-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050606-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050606-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050606-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050606-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050606-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050606-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050606-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050606-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050606-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050606-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050606-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050606-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050606-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050606-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N050606-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050606-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050606-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050606-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050606-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050606-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050606-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050606-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050606-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050606-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050606-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050606-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050606-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050606-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050606-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050606-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050606-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050606-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050606-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050606-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N050606-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Vancocin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VANCOMYCIN HYDROCHLORIDE125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
71WO621TJDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
201848Internal RxNorm lookup
201849Internal RxNorm lookup
313570Internal RxNorm lookup
313571Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a078d9c2-f89c-4f9f-8ded-60ffb2983c3fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
518d3e87-1791-43fd-b421-7f508923e5f1Product name420260107
8c6bdc15-c879-407f-914d-b44fce8e7bbdProduct name120240730
324cd4ef-8967-4991-91fd-3046d51874b9Product name220240118
ba2497d8-e8e9-d71b-251e-24ac323bbaa3Product name920231206
01f96903-8ada-4a91-9a58-9f8e51b7a70aProduct name120230922
e5c5573a-2fda-453b-9d65-c6185b588ecdProduct name520220613
3a86dfd0-ed28-4976-b9ec-00923fbfbdd4Product name120220308
5d603187-d384-6e74-5fc7-30310b2b3c99Product name320190717
bec007f0-8cd6-4f79-a3df-c0d94ebb2a36Product name120190614
f4fec0bc-aaaa-4c5c-aa2b-21daf18ef477Product name120160209
a0c54c75-e1f1-eb4f-25c4-be91c2fe237dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-310-20Vancocin2 in 1 CARTONCAPSULE212
62559-310-20Vancocin10 in 1 BLISTER PACKCAPSULE1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-310-20EA - Each62559-3105cfcccc7-7865-4d81-9d34-9301790631f112014-12-01

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-310VANCOCIN (VANCOMYCIN HYDROCHLORIDE) CAPSULE [ANI PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 2 package rows20240802_a078d9c2-f89c-4f9f-8ded-60ffb2983c3f.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEANI Pharmaceuticals, Inc.3707ad2e-5c82-4111-a370-e518e5e7e4c52026-03-02Warnings, Adverse reactionsExact identifier
application applno (NDA): 050606
application number: NDA050606
VancocinVANCOMYCIN HYDROCHLORIDEANI Pharmaceuticals, Inc.a078d9c2-f89c-4f9f-8ded-60ffb2983c3f2025-12-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 050606
application number: NDA050606
ndc (product): 62559-310
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDERedpharm Drug3745b502-c222-e307-e063-6394a90a697e2025-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 050606
application number: NDA050606
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC33127951-1fad-15c1-e063-6294a90a69962025-04-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 050606
application number: NDA050606

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
201848Vancocin 125 MG Oral CapsulePSNa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
201849Vancocin 250 MG Oral CapsulePSNa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
313570vancomycin HCl 125 MG Oral CapsulePSNa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
313571vancomycin HCl 250 MG Oral CapsulePSNa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
201848vancomycin 125 MG Oral Capsule [Vancocin]SBDa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
201849vancomycin 250 MG Oral Capsule [Vancocin]SBDa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
313570vancomycin 125 MG Oral CapsuleSCDa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
313571vancomycin 250 MG Oral CapsuleSCDa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
201848Vancocin (as vancomycin hydrochloride) 125 MG Oral CapsuleSYa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
201849Vancocin (as vancomycin hydrochloride) 250 MG Oral CapsuleSYa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
201848Vancocin 125 MG Oral CapsuleSYa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
201849Vancocin 250 MG Oral CapsuleSYa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
313570vancomycin (as vancomycin hydrochloride) 125 MG Oral CapsuleSYa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12
313571vancomycin (as vancomycin hydrochloride) 250 MG Oral CapsuleSYa078d9c2-f89c-4f9f-8ded-60ffb2983c3f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-310-20625590310202 BLISTER PACK in 1 CARTON (62559-310-20) / 10 CAPSULE in 1 BLISTER PACK2 blister pack2014-11-170000-00-00NoNoCurrent