Penicillin V Potassium

Product NDC: 62135-103
Requested package NDC: 62135-103-01
11-digit product format: 621350103
Labeler code: 62135
Product ID: 62135-103_574b2e4e-febe-2db9-e063-6394a90a3474
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Penicillin V Potassium
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA060456
Marketing category: ANDA
Marketing start: 1990-09-30
Substance: PENICILLIN V POTASSIUM
Active strength: 250 mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC]; Penicillins [CS]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A060456-001	PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982
A060456-002	PENICILLIN-VK	PENICILLIN V POTASSIUM	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982

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
2026-08-01 22:54:32	2026-06	A060456-001	PENICILLIN-VK	EQ 125MG BASE/5ML	FOR SOLUTION / ORAL		Approved before 1982		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A060456-002	PENICILLIN-VK	EQ 250MG BASE/5ML	FOR SOLUTION / ORAL		RS, Approved before 1982		`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Penicillin V Potassium	PENICILLIN V POTASSIUM	Chartwell RX, LLC	b0744674-ddf7-4022-be2f-2a22bef0d379	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456 ndc (package): 62135-103-01 ndc (product): 62135-103 ndc11 (package): 62135010301
Penicillin V Potassium	PENICILLIN V POTASSIUM	Preferred Pharmaceuticals, Inc	8c342c78-47fb-4f6b-9451-68b1f752555c	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456
Penicillin V Potassium	PENICILLIN V POTASSIUM	NuCare Pharmaceuticals,Inc.	55a44735-6d6e-3012-e054-00144ff8d46c	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456
Penicillin V Potassium	PENICILLIN V POTASSIUM	A-S Medication Solutions	ded0ee2e-56ae-41fe-949c-177614cd8e1f	2023-09-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456
Penicillin V Potassium	PENICILLIN V POTASSIUM	Teva Pharmaceuticals USA, Inc.	3111ca84-6f8e-45ea-91a1-9cb99c63607e	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456
Penicillin V Potassium	PENICILLIN V POTASSIUM	Proficient Rx LP	316aa904-09f1-4a8e-9adf-93cfc14f9a0a	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 060456 application number: ANDA060456

Additional Listing Data#

Finished product: Yes
Brand name base: Penicillin V Potassium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PENICILLIN V POTASSIUM	250 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
146T0TU1JB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
834040	Internal RxNorm lookup
834046	Internal RxNorm lookup
834061	Internal RxNorm lookup
834102	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
b0744674-ddf7-4022-be2f-2a22bef0d379	Available on FDA.report

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
146T0TU1JB	PENICILLIN V POTASSIUM	132-98-9	PENICILLIN V POTASSIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Status
62135-103-01	62135010301	100 mL in 1 BOTTLE (62135-103-01)	100 ml	2026-07-16	0	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Penicillin V Potassium Tablets, USP Penicillin V Potassium for Oral Solution, USP	Chartwell RX, LLC	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	2